PMA Final Decisions for February 2012 - Medical Design and Outsourcing

Below are Premarket Approvals (PMA), Product Development
Protocols (PDP), Supplement and Notice Decisions. This list is
generated on a monthly basis.

A PDF document that contains the “Approval letter and Summary of
Safety and Effectiveness” is being added to this listing for each
PMA. The PMA number will appear as a link if this document is
available.

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P080012 2/7/12	Prometra Programmable Infusion Pump System	Medasys, Incorporated Mount Olive, NJ 07828	Approval for the Prometra Programmable Infusion Pump System. The device is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).
P100007 2/10/12	Breast Companion® Software System	Almen Laboratories, Inc. Vista, CA 92084	Approval for the Breast Companion® Software System. The Breast Companion® is a computer-aided system intended for improving the ACR BI-RADS assessment of ultrasound images of lesions of the female breast as part of the diagnostic workshop.
P100025 2/22/12	BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0	Otsuka America Pharmaceutical, Inc. Rockville, MD 20850	Approval for the BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0. This device is indicated for: The BreathTek UBT for H pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of ¹³CO₂ to ¹²CO₂ in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician.
P100033 2/13/12	PROGENSA® PCA3 Assay	Gen-Probe Incorporated San Diego, CA 92121	Approval for the PROGENSA® PCA3 Assay. This device is indicated for: PROGENSA® PCA3 Assay is an in vitro nucleic acid amplification test. The assay measures the concentration of prostate cancer gene 3 (PCA3) and prostate-specific antigen (PSA) RNA (RNA) molecules and calculates the ratio of PCA3 RNA molecules to PSA RNA molecules (PCA3 Score) in post digital rectal exam (DRE) first catch male urine specimens. The PROGENSA® PCA3 Assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care, before consideration of PROGENSA® PCA3 Assay results. A PCA3 score <25 is associated with a decreased likelihood of a positive biopsy. Prostatic biopsy is required for diagnosis of cancer.
P110013 2/17/12	Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System and Resolute Integrity Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Approval for the Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System and Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems. These devices are indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length 27 ≤ mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm.
P110028 2/22/12	Absolute Pro® Vascular Self-Expanding Stent System	Abbott Vascular Santa Clara, CA 95054	Approval for the Absolute Pro® Vascular Self-Expanding Stent System. The device is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesions lengths up to 90 mm.

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N18033/S061 2/1/12 135-Day	VISTAKON (etafilcon A) Brand Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Approval for the implementation of an alternate test method for determining the purity of the raw materials used in reactive monomer mix formulation.
N18286/S022 2/29/12 Real-Time	Gelfoam (absorbable gelatin) Sterile Sponge	Pfizer, Inc. New York, NY 10017	Approval for a new convenience kit, Gelfoam Plus – Powder to be comprised of Gelfoam Powder, human thrombin, one syringe that is pre-filled with 0.9% NaC1 solution, one empty syringe, a needleless transfer device and an applicator tip.
P820076/S025 2/24/12 135-Day	Diplos Dual Chamber Pacing Systems	Biotronik, Inc. Lake Oswego, OR 97035	Approval for addition of an automated production test process.
P830037/S053 2/7/12 180-Day	FreshLook® UV Spherical and FreshLook® Toric	CIBA VISION Corporation Duluth, GA 30097	Approval for the use of the new Phoenix VT print pads used to transfer inks onto the lens surface and for the addition of a pre-conditioning step for optimal ink adhesion onto the lenses when the new print pad is utilized.
P830055/S121 2/9/12 Real-Time	LCS Total Knee System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval for the addition of mobile bearing Attune CR (cruciate retaining) RP (rotating platform) tibial bases and tibial inserts for use with previously cleared femoral and patellar components. The device, as modified, will be marketed under the trade name Attune Rotating Platform (RP) Total Knee System and is indicated for use in total knee replacement in patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
P830055/S122 2/6/12 Real-Time	LCS Total Knee System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval for the addition of TruMatch Patient Specific Instruments (patient-matched cutting/drilling guides) as optional instrumentation to use with femoral and tibial components.
P830055/S125 2/21/12	LCS Total Knee System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval for additional inspection steps to the manufacturing process of the Sigma PS Femoral Components, Sigma PS Femoral Components with Lugs and Sigma RPF Femoral Components.
P850048/S026 2/17/12 Real-Time	Access Hybritech PSA Reagents on the Access Immunoassay Systems	Beckman Coulter, Inc. Chaska, MN 55318	Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P860004/S161 2/16/12 135-Day	SynchroMed II Infusion Pump	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for automating the transfer of endotoxin testing data into the FACTORY works execution system.
P860004/S167 2/17/12 Real-Time	Indura 1 Piece Intrathecal Catheter with Sutureless Connector, Intrathecal Catheter with Sutureless Connector, Intrathecal Catheter Pump Segment Revision Kit with Sutureless Connector, Sutureless Pump Connector Revision Kit for Intrathecal Catheters	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for the Sutureless Connector (SC) catheter Models 8709SC and 8731SC, and revision kit Models 8578 and 8596SC to address the potential for side load leaks. The modifications to your sutureless connector are as follows: 1) decreased the counter bore diameter from 0.040″ to 0.035″ ; 2) decreased the depth of the counter bore from 0.055″ to 0.050″ ; 3) increased the tolerance for the 0.15″ dimension of the tubing position from ± 0.01to ± 0 .0 2; and 4) added a requirement to the product specification for side load forces: Connecto r must not occlude or leak when pressurized to 1.0 ± 0.1 psig air pressure and a force of 4.8 ± 0.1 l bf is distributed over the connector surface at an angle of 12° ± 2° .
P860047/S025 2/3/12 180-Day	OcuCoat (2% Hydroxypropyl- methylcellulose) Syringe Product	Bausch & Lomb, Inc. Aliso Viejo, CA 92656	Approval for an alternate elastomeric tip cap material (FM27) and the addition of a threaded Plastic Rigid Tip Cap (PRTC) outer shell.
P910001/S051 2/17/12 135-Day	Excimer Laser Coronary Atherectomy (ELCA) Catheters	Spectranetics Corporation Colorado Springs, CO 80921	Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.
P910065/S008 2/13/12 180-Day	ST AIA-PACK PA	Tosoh Bioscience, Inc. South San Francisco, CA 94080	Approval for the addition of one FDA-cleared Tosoh Automated Immunoassay Analyzer, the AIA-900, for use with the ST AIA-PACK PA assay.
P950005/S033 2/8/12 135-Day	CELSIUS® and CELSIUS® II Diagnostic/Ablation Deflectable Tip Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for an increase in the number of allowed EtO sterilization cycles, and a modification to the workmanship inspection performed by Quality Control.
P950032/S067 2/22/12 Real-Time	Apligraf (Graftskin)	Organogenesis, Inc. Canton, MA 02021	Approval for the introduction of Human Epidermal Keratinocyte cell strain (HEP 158) into the manufacture of the device.
P950034/S040 2/17/12 135-Day	Seprafilm Adhesion Barrier	Genzyme Corporation Framingham, MA 01701	Approval for implementing a new compressed air system.
P950037/S097 2/24/12 135-Day	Dromos DR/SR Rate Adaptive Pacing Systems	Biotronik, Inc. Lake Oswego, OR 97035	Approval for addition of an automated production test process.
P950042/S007 2/2/12 180-Day	PINPOINT Endoscopic Light Source and Video Camera	Novadaq Technologies, Incorporated Richmond, British Columbia, Canada V6V 2A2	Approval for a change in the trade name of the medical device from PINPOINT to ONCO-LIFE Endoscopic Light Source and Video Camera.
P960009/S134 2/3/12 Real-Time	Deep Brain Stimulation (DBS) Extension Kits	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for removal of the tunneling tool and tunneling tool accessories from Deep Brain Stimulation (DBS) extension kits, Models 7472A and 37085.
P960042/S032 2/17/12 135-Day	Spectranetics Laser Sheaths (SLS)	Spectranetics Corporation Colorado Springs, CO 80921	Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.
P970008/S060 2/3/12 Real-Time	Urologix Targis® System	Urologix, Inc. Minneapolis, MN 55447	Approval for minor changes to the software for the Targis® System CoolWave® Control Unit Model 5000 and associated changes to the User Manual. The device, as modified, will be marketed under the trade name Urologix Targis® System and is indicated for the relief of symptoms and obstructions associated with Benign Prostatic Hyperplasia (BPH) for men with prostatic urethral lengths of 2.5-3.5cm (short antenna), or 3.0-5.0cm (standard antenna), or 4.5+cm (long antenna).
P970029/S014 2/22/12 180-Day	TMR2000 Holmium Laser System	Cardiogenesis Corporation Kennesaw, GA 30144	Approval for the PEARL 8.0 handpiece.
P970038/S015 2/17/12 Real-Time	Access Hybritech Free PSA Reagents on the Access Immunoassay Systems	Beckman Coulter, Inc. Chaska, MN 55318	Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P970051/S089 2/28/12 Real-Time	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for the CP800 Series Soft Earhook, which is an accessory to the CP810 Sound Processor that acts as an alternative to the currently marketed CP800 Series Earhook.
P980003/S034 2/15/12 Real-Time	Chilli Cooled Ablation System – CircuCool Pump	Boston Scientific Corporation San Jose, CA 95134	Approval for five changes to address the failure of a micro switch designed to automatically shut off the pump if the roller bed cover is opened without turning off the power switch. These changes include: 1) Introducing a new micro switch which features an auxiliary actuator which eliminates direct contact between the retainer screw and the actuator button; 2) Adding a secondary shoulder on the retainer screw to limit the screw penetration depth to coincide with the tolerance stack up with the micro switch position; 3) Minor dimension and tolerance changes to the mounting plate to accommodate the new micro switch; 4) Use “counter-sink” holes instead of “straight-through” holes in the pump head to secure the mounting plate, ensuring bracket alignment and minimizing “play” in the bracket installation; and 5) Adding an inspection step and test fixture to verify the installed position of the micro switch relative to the pump head.
P980022/S107 2/6/12 Real-Time	iPro2 Professional Continuous Glucose Monitoring System	Medtronic, Inc. Northridge, CA 91325	Approval for software changes to the CareLink iPro Therapy Management Software (MMT-7340, version 1.4A) for use with the device.
P980023/S046 2/22/12 180-Day	Vigila and Volta Defibrillation Leads	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the following: 1) addition of trade names Vigila and Volta for the Linox and Linox smart defibrillation leads; 2) change to Indications for Use statement to clarify that the Vigila and Volta leads may be used with any manufacturers’ ICDs; and 3) accessory kits for use with the Vigila and Volta leads.
P980024/S006 2/27/12 135-Day	PathVysion HER-2 DNA Probe Kit	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for manufacturing process changes to the PathVysion HER-2 DNA Probe Kit, including changes associated with FISH probe restriction enzyme digested gel electrophoresis (DNA restriction analysis), implementation of an in-process validated test method for A260 absorbance readings, addition of an incoming screening test for dextran sulfate and revision to manufacturing procedure document for LSI HER-2/neu aminated DNA.
P980041/S016 2/17/12 Real-Time	Access AFP Reagents on the Access Immunoassay Systems	Beckman Coulter, Inc. Chaska, MN 55318	Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P990056/S014 2/24/12 180-Day	Elecsys Total PSA (tPSA) Test System	Roche Diagnostics Indianapolis, IN 46250	Approval for extension of the Elecsys Total PSA (tPSA) test system onto the cobas e 602 immunoassay analyzer.
P000006/S024 2/13/12 Real-Time	Titan Inflatable Penile Prosthesis	Coloplast Corporation Minneapolis, MN 55411	Approval for: 1) a change in the angle of the tubing on the cylinder from the current 45° to 0° angle to improve the ease of implantation; and 2) to change the tip material from dipped-on Bioflex to bonded-on MED 4750.
P000027/S012 2/24/12 180-Day	Elecsys Free PSA (fPSA) Test System	Roche Diagnostics Indianapolis, IN 46250	Approval for extension of the Elecsys Free PSA (fPSA) test system onto the cobas e 602 immunoassay analyzer.
P000037/S024 2/17/12 135-Day	On-X Prosthetic Heart Valve	On-X Life Technologies Austin, TX 78752	Approval for relocating a sealing machine from a contract manufacturer to in-house.
P000041/S011 2/27/12 180-Day	ClearRead™ Detect	Riverain Medical Group, LLC Miamisburg, OH 45342	Approval to market the device under the additional trade name ClearRead Detect.
P010001/S010 2/14/12 135-Day	Trascend Hip Articulation System	CeramTec GmbH Ferndale, MI 48220	Approval for the addition of an alternate polishing machine at the Plochingen, Germany facility.
P010012/S280 2/16/12 Real-Time	LV-1 Lead Port Plug	Boston Scientific Corporation St. Paul, MN 55112	Approval for a shelf life extension from 4 years to 5 years for the subject LV-1 lead port plug.
P010014/S033 2/3/12 Special	Oxford® Partial Knee System	Biomet Manufacturing Corporation Warsaw, IN 46581	Approval for an additional labeling piece entitled “Oxford Partial Knee X-Ray Protocol”.
P010068/S023 2/8/12 135-Day	NAVISTAR® Dual Sensor 8mm Diagnostic/Ablation Deflectable Tip Catheter	Biosense Webster, Inc. Diamond Bar, CA 91765	Approval for an increase in the number of allowed EtO sterilization cycles, and a modification to the workmanship inspection performed by Quality Control.
P020012/S006 2/9/12 180-Day	Artefill PMMA Collagen Dermal Filler	Suneva Medical, Inc. San Diego, CA 92121	Approval for a manufacturing site located at Suneva Medial, Inc. in San Diego, California.
P020014/S017 2/24/12 180-Day	Essure System for Permanent Birth Control	Conceptus, Inc. Mountain View, CA 94041	Approval to modify the existing RF energy warning to add an Essure/ NovaSure warning. Additionally, the PMA supplement includes approval of a post-approval study.
P020014/S033 2/22/12 180-Day	Essure System for Permanent Birth Control	Conceptus, Inc. Mountain View, CA 94041	Approval for an alternate hydrophilic coating of the delivery catheter.
P030005/S081 2/16/12 Real-Time	LV-1 Lead Port Plug	Boston Scientific Corporation St. Paul, MN 55112	Approval for a shelf life extension from 4 years to 5 years for the subject LV-1 lead port plug.
P030017/S124 2/1/12 135-Day	Precision® Spinal Cord Stimulator System	Boston Scientific Neuromodulation Valencia, CA 91355	Approval for Ethylene Oxide sterilization equipment and its associated sterilization cycles.
P030025/S086 2/22/12 Panel-Track	TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)	Boston Scientific Corporation Maple Grove, MN 55311	Approval to expand the labeled indications for the TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System. The TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions ≤ 28 mm in length; 2) in patients undergoing primary angioplasty to treat acute ST-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and < 12 hours in duration; or 3) within bare metal stent restenotic lesions 2.50 mm to 3.75 mm in diameter and ≤ 28 mm in length.
P040044/S039 2/13/12 135-Day	Mynx Vascular Closure Device Product Family	Access Closure, Inc. Mountain View, CA 94043	Approval for modifications to the balloon tube necking process.
P040045/S026 2/1/12 135-Day	VISTAKON (senofilcon A) Brand Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Approval for the implementation of an alternate test method for determining the purity of the raw materials used in reactive monomer mix formulation.
P050034/S006 2/23/12 Real-Time	Implantable Miniature Telescope™	VisionCare Ophthalmic Technologies Saratoga, CA 95070	Approval for the addition of the information regarding the safety of the device during MRI exposure to the Patient Information Booklet.
P050043/S006 2/28/12 Real-Time	Femoral Introducer Sheath and Hemostatic Device (FISH), FISH-SP Device	Morris Innovative, Inc. Bloomington, IN 47403	Approval for a new version of the sub-intestinal submucosa (SIS) material (Version 2.0).
P050047/S022 2/24/12 Special	Juvèderm Hyaluronate Gel Implants	Allergan Goleta, CA 93117	Approval for the addition of a new Precaution Statement: “Failure to comply with these instructions could result in needle disengagement and/or product leakage at te Luer-lock needle hub connection.”
P060008/S046 2/22/12 Panel-Track	TAXUS Libertè Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)	Boston Scientific Corporation Maple Grove, MN 55311	Approval to expand the labeled indications for the TAXUS Libertè Paclitaxel-Eluting Coronary Stent System. The TAXUS® Libertè® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Systems) is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.75 mm to 4.00 mm in diameter in lesions ≤ 34 mm in length; 2) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 2.50 mm in diameter in lesions ≤ 28 mm in length; or 3) in patients undergoing primary angioplasty to treat acute St-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and < 12 hours in duration.
P060029/S003 2/3/12 180-Day	ETHICON OMNEX Surgical Sealant	Ethicon, Inc. Somerville, NJ 08876	Approval for a manufacturing site located at Ethicon LLC., in San Lorenzo, Puerto Rico.
P070008/S024 2/24/12 135-Day	Stratos LV/LV-T Resynchronization Therapy Pacemaker Systems	Biotronik, Inc. Lake Oswego, OR 97035	Approval for addition of an automated production test process.
P070022/S026 2/9/12 180-Day	Adiana Permanent Contraception System	Hologic, Inc. Marlborough, MA 01752	Approval for a manufacturing site located at Hologic Costa Rica SA., in Alajuela, Costa Rica.
P080011/S009 2/24/12 Special	CooperVision Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Approval for an additional density check of the lens extraction/hydration tanks.
P080025/S022 2/10/12 180-Day	Medtronic InterStim® Therapy System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for design and specification changes to the Model 3058 InterStim II battery.
P100023/S015 2/22/12 Panel-Track	ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire)	Boston Scientific Corporation Maple Grove, MN 55311	Approval to expand the labeled indications for the ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire). The ION™ Stent System is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions ≤ 34 mm in length; or 2) in patients undergoing primary angioplasty to treat acute ST-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting > 20 minutes and > 12 hours in duration.
P100024/S001 2/1/12 Real-Time	HER2 CISH pharmDx™ Kit	Dako Denmark A/S Glostrup, Denmark DK-2600	Approval for an update of the software documentation for DakoLink software version 3.0 to DakoLink version 3.1.1.
P100027/S002 2/15/12 180-Day	INFORM HER2 Dual ISH DNA Probe Cocktail Assay	Ventana Medical Systems, Inc. Tucson, AZ 85755	Approval for migration of the INFORM HER2 Dual ISH DNA Probe Cocktail assay to the BenchMark Ultra Auto-stainer. The device, as modified, will be marketed under the trade name INFORM HER2 Dual ISH DNA Probe Cocktail assay and is indicated “for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark XT automated slide stainers (using NexES software), or on Ventana BenchMark ULTRA automated slide stainer (using VSS software), by light microscopy. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom HERCEPTIN (trastuzumab) treatment is being considered. This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls. This reagent is intended for in vitro diagnostic (IVD) use.”

APPLICATION NUMBER / DATE of
APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, &
ZIP

DEVICE DESCRIPTION /
INDICATIONS

N18033/S061

2/1/12

135-Day

VISTAKON (etafilcon A) Brand Contact Lenses

Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Approval for the implementation of an alternate test method for
determining the purity of the raw materials used in reactive
monomer mix formulation.

N18286/S022

2/29/12

Real-Time

Gelfoam (absorbable gelatin) Sterile Sponge

Pfizer, Inc.

New York, NY

10017

Approval for a new convenience kit, Gelfoam Plus – Powder
to be comprised of Gelfoam Powder, human thrombin, one syringe that
is pre-filled with 0.9% NaC1 solution, one empty syringe, a
needleless transfer device and an applicator tip.

P820076/S025

2/24/12

135-Day

Diplos Dual Chamber Pacing Systems

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for addition of an automated production test
process.

P830037/S053

2/7/12

180-Day

FreshLook® UV Spherical and FreshLook® Toric

CIBA VISION Corporation

Duluth, GA

30097

Approval for the use of the new Phoenix VT print pads used to
transfer inks onto the lens surface and for the addition of a
pre-conditioning step for optimal ink adhesion onto the lenses when
the new print pad is utilized.

P830055/S121

2/9/12

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the addition of mobile bearing Attune CR (cruciate
retaining) RP (rotating platform) tibial bases and tibial inserts
for use with previously cleared femoral and patellar components.
The device, as modified, will be marketed under the trade name
Attune Rotating Platform (RP) Total Knee System and is indicated
for use in total knee replacement in patients with a severely
painful and/or severely disabled joint resulting from
osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or
a failed previous implant.

P830055/S122

2/6/12

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the addition of TruMatch Patient Specific
Instruments (patient-matched cutting/drilling guides) as optional
instrumentation to use with femoral and tibial components.

P830055/S125

2/21/12

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for additional inspection steps to the manufacturing
process of the Sigma PS Femoral Components, Sigma PS Femoral
Components with Lugs and Sigma RPF Femoral Components.

P850048/S026

2/17/12

Real-Time

Access Hybritech PSA Reagents on the Access Immunoassay
Systems

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the change in polypropylene resin used for
manufacturing of the reagent pack container.

P860004/S161

2/16/12

135-Day

SynchroMed II Infusion Pump

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for automating the transfer of endotoxin testing data
into the FACTORY works execution system.

P860004/S167

2/17/12

Real-Time

Indura 1 Piece Intrathecal Catheter with Sutureless Connector,
Intrathecal Catheter with Sutureless Connector, Intrathecal
Catheter Pump Segment Revision Kit with Sutureless Connector,
Sutureless Pump Connector Revision Kit for Intrathecal
Catheters

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for the Sutureless Connector (SC) catheter Models
8709SC and 8731SC, and revision kit Models 8578 and 8596SC to
address the potential for side load leaks. The modifications to
your sutureless connector are as follows:

1) decreased the counter bore diameter from 0.040″ to 0.035″
;

2) decreased the depth of the counter bore from 0.055″ to 0.050″ ;
3) increased the tolerance for the 0.15″ dimension of the tubing
position from ± 0.01to ± 0 .0 2; and 4) added a
requirement to the product specification for side load forces:
Connecto r must not occlude or leak when pressurized to 1.0
± 0.1 psig air pressure and a force of 4.8 ± 0.1 l bf
is distributed over the connector surface at an angle of 12°
± 2° .

P860047/S025

2/3/12

180-Day

OcuCoat (2% Hydroxypropyl-

methylcellulose) Syringe Product

Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Approval for an alternate elastomeric tip cap material (FM27)
and the addition of a threaded Plastic Rigid Tip Cap (PRTC) outer
shell.

P910001/S051

2/17/12

135-Day

Excimer Laser Coronary Atherectomy (ELCA) Catheters

Spectranetics Corporation

Colorado Springs, CO

80921

Approval for the use of a new sterilization chamber, new
sterilization cycle, change in packaging configuration for
sterilization, and a change in the sterile load configuration.

P910065/S008

2/13/12

180-Day

ST AIA-PACK PA

Tosoh Bioscience, Inc.

South San Francisco, CA

94080

Approval for the addition of one FDA-cleared Tosoh Automated
Immunoassay Analyzer, the AIA-900, for use with the ST AIA-PACK PA
assay.

P950005/S033

2/8/12

135-Day

CELSIUS® and CELSIUS® II Diagnostic/Ablation
Deflectable Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for an increase in the number of allowed EtO
sterilization cycles, and a modification to the workmanship
inspection performed by Quality Control.

P950032/S067

2/22/12

Real-Time

Apligraf (Graftskin)

Organogenesis, Inc.

Canton, MA

02021

Approval for the introduction of Human Epidermal Keratinocyte
cell strain (HEP 158) into the manufacture of the device.

P950034/S040

2/17/12

135-Day

Seprafilm Adhesion Barrier

Genzyme Corporation

Framingham, MA

01701

Approval for implementing a new compressed air system.

P950037/S097

2/24/12

135-Day

Dromos DR/SR Rate Adaptive Pacing Systems

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for addition of an automated production test
process.

P950042/S007

2/2/12

180-Day

PINPOINT Endoscopic Light Source and Video Camera

Novadaq Technologies, Incorporated

Richmond, British Columbia, Canada

V6V 2A2

Approval for a change in the trade name of the medical device
from PINPOINT to ONCO-LIFE Endoscopic Light Source and Video
Camera.

P960009/S134

2/3/12

Real-Time

Deep Brain Stimulation (DBS) Extension Kits

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for removal of the tunneling tool and tunneling tool
accessories from Deep Brain Stimulation (DBS) extension kits,
Models 7472A and 37085.

P960042/S032

2/17/12

135-Day

Spectranetics Laser Sheaths (SLS)

Spectranetics Corporation

Colorado Springs, CO

80921

Approval for the use of a new sterilization chamber, new
sterilization cycle, change in packaging configuration for
sterilization, and a change in the sterile load configuration.

P970008/S060

2/3/12

Real-Time

Urologix Targis® System

Urologix, Inc.

Minneapolis, MN

55447

Approval for minor changes to the software for the Targis®
System CoolWave® Control Unit Model 5000 and associated changes
to the User Manual. The device, as modified, will be marketed under
the trade name Urologix Targis® System and is indicated for the
relief of symptoms and obstructions associated with Benign
Prostatic Hyperplasia (BPH) for men with prostatic urethral lengths
of 2.5-3.5cm (short antenna), or 3.0-5.0cm (standard antenna), or
4.5+cm (long antenna).

P970029/S014

2/22/12

180-Day

TMR2000 Holmium Laser System

Cardiogenesis Corporation

Kennesaw, GA

30144

Approval for the PEARL 8.0 handpiece.

P970038/S015

2/17/12

Real-Time

Access Hybritech Free PSA Reagents on the Access Immunoassay
Systems

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the change in polypropylene resin used for
manufacturing of the reagent pack container.

P970051/S089

2/28/12

Real-Time

Nucleus 24 Cochlear Implant System

Cochlear Americas

Centennial, CO

80111

Approval for the CP800 Series Soft Earhook, which is an
accessory to the CP810 Sound Processor that acts as an alternative
to the currently marketed CP800 Series Earhook.

P980003/S034

2/15/12

Real-Time

Chilli Cooled Ablation System – CircuCool Pump

Boston Scientific Corporation

San Jose, CA

95134

Approval for five changes to address the failure of a micro
switch designed to automatically shut off the pump if the roller
bed cover is opened without turning off the power switch. These
changes include:

1) Introducing a new micro switch which features an auxiliary
actuator which eliminates direct contact between the retainer screw
and the actuator button; 2) Adding a secondary shoulder on the
retainer screw to limit the screw penetration depth to coincide
with the tolerance stack up with the micro switch position;

3) Minor dimension and tolerance changes to the mounting plate to
accommodate the new micro switch; 4) Use “counter-sink”
holes instead of “straight-through” holes in the pump
head to secure the mounting plate, ensuring bracket alignment and
minimizing “play” in the bracket installation;
and

5) Adding an inspection step and test fixture to verify the
installed position of the micro switch relative to the pump
head.

P980022/S107

2/6/12

Real-Time

iPro2 Professional Continuous Glucose Monitoring System

Medtronic, Inc.

Northridge, CA

91325

Approval for software changes to the CareLink iPro Therapy
Management Software (MMT-7340, version 1.4A) for use with the
device.

P980023/S046

2/22/12

180-Day

Vigila and Volta Defibrillation Leads

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the following:

1) addition of trade names Vigila and Volta for the Linox and
Linox smart defibrillation leads; 2) change to Indications for Use
statement to clarify that the Vigila and Volta leads may be used
with any manufacturers’ ICDs; and 3) accessory kits for use with
the Vigila and Volta leads.

P980024/S006

2/27/12

135-Day

PathVysion HER-2 DNA Probe Kit

Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval for manufacturing process changes to the PathVysion
HER-2 DNA Probe Kit, including changes associated with FISH probe
restriction enzyme digested gel electrophoresis (DNA restriction
analysis), implementation of an in-process validated test method
for A260 absorbance readings, addition of an incoming screening
test for dextran sulfate and revision to manufacturing procedure
document for LSI HER-2/neu aminated DNA.

P980041/S016

2/17/12

Real-Time

Access AFP Reagents on the Access Immunoassay Systems

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the change in polypropylene resin used for
manufacturing of the reagent pack container.

P990056/S014

2/24/12

180-Day

Elecsys Total PSA (tPSA) Test System

Roche Diagnostics

Indianapolis, IN

46250

Approval for extension of the Elecsys Total PSA (tPSA) test
system onto the cobas e 602 immunoassay analyzer.

P000006/S024

2/13/12

Real-Time

Titan Inflatable Penile Prosthesis

Coloplast Corporation

Minneapolis, MN

55411

Approval for: 1) a change in the angle of the tubing on the
cylinder from the current 45° to 0° angle to improve the
ease of implantation; and 2) to change the tip material from
dipped-on Bioflex to bonded-on MED 4750.

P000027/S012

2/24/12

180-Day

Elecsys Free PSA (fPSA) Test System

Roche Diagnostics

Indianapolis, IN

46250

Approval for extension of the Elecsys Free PSA (fPSA) test
system onto the cobas e 602 immunoassay analyzer.

P000037/S024

2/17/12

135-Day

On-X Prosthetic Heart Valve

On-X Life Technologies

Austin, TX

78752

Approval for relocating a sealing machine from a contract
manufacturer to in-house.

P000041/S011

2/27/12

180-Day

ClearRead™ Detect

Riverain Medical Group, LLC

Miamisburg, OH

45342

Approval to market the device under the additional trade name
ClearRead Detect.

P010001/S010

2/14/12

135-Day

Trascend Hip Articulation System

CeramTec GmbH

Ferndale, MI

48220

Approval for the addition of an alternate polishing machine at
the Plochingen, Germany facility.

P010012/S280

2/16/12

Real-Time

LV-1 Lead Port Plug

Boston Scientific Corporation

St. Paul, MN

55112

Approval for a shelf life extension from 4 years to 5 years for
the subject LV-1 lead port plug.

P010014/S033

2/3/12

Special

Oxford® Partial Knee System

Biomet Manufacturing Corporation

Warsaw, IN

46581

Approval for an additional labeling piece entitled
“Oxford Partial Knee X-Ray Protocol”.

P010068/S023

2/8/12

135-Day

NAVISTAR® Dual Sensor 8mm Diagnostic/Ablation Deflectable
Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for an increase in the number of allowed EtO
sterilization cycles, and a modification to the workmanship
inspection performed by Quality Control.

P020012/S006

2/9/12

180-Day

Artefill PMMA Collagen Dermal Filler

Suneva Medical, Inc.

San Diego, CA

92121

Approval for a manufacturing site located at Suneva Medial,
Inc. in San Diego, California.

P020014/S017

2/24/12

180-Day

Essure System for Permanent Birth Control

Conceptus, Inc.

Mountain View, CA

94041

Approval to modify the existing RF energy warning to add an
Essure/ NovaSure warning. Additionally, the PMA supplement includes
approval of a post-approval study.

P020014/S033

2/22/12

180-Day

Essure System for Permanent Birth Control

Conceptus, Inc.

Mountain View, CA

94041

Approval for an alternate hydrophilic coating of the delivery
catheter.

P030005/S081

2/16/12

Real-Time

LV-1 Lead Port Plug

Boston Scientific Corporation

St. Paul, MN

55112

Approval for a shelf life extension from 4 years to 5 years for
the subject LV-1 lead port plug.

P030017/S124

2/1/12

135-Day

Precision® Spinal Cord Stimulator System

Boston Scientific Neuromodulation

Valencia, CA

91355

Approval for Ethylene Oxide sterilization equipment and its
associated sterilization cycles.

P030025/S086

2/22/12

Panel-Track

TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System
(Monorail and Over-the-Wire)

Boston Scientific Corporation

Maple Grove, MN

55311

Approval to expand the labeled indications for the TAXUS
Express 2 Paclitaxel-Eluting Coronary Stent System. The TAXUS
Express 2 Paclitaxel-Eluting Coronary Stent System is indicated for
improving luminal diameter: 1) for the treatment of de novo lesions
in native coronary arteries 2.25 mm to 4.00 mm in diameter in
lesions ≤ 28 mm in length; 2) in patients undergoing primary
angioplasty to treat acute ST-segment elevation myocardial
infarction, true posterior myocardial infarction, or presumed new
left bundle branch block with symptoms of acute myocardial
infarction lasting

> 20 minutes and

< 12 hours in duration; or

3) within bare metal stent restenotic lesions 2.50 mm to 3.75 mm
in diameter and ≤ 28 mm in length.

P040044/S039

2/13/12

135-Day

Mynx Vascular Closure Device Product Family

Access Closure, Inc.

Mountain View, CA

94043

Approval for modifications to the balloon tube necking
process.

P040045/S026

2/1/12

135-Day

VISTAKON (senofilcon A) Brand Contact Lenses

Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Approval for the implementation of an alternate test method for
determining the purity of the raw materials used in reactive
monomer mix formulation.

P050034/S006

2/23/12

Real-Time

Implantable Miniature Telescope™

VisionCare Ophthalmic Technologies

Saratoga, CA

95070

Approval for the addition of the information regarding the
safety of the device during MRI exposure to the Patient Information
Booklet.

P050043/S006

2/28/12

Real-Time

Femoral Introducer Sheath and Hemostatic Device (FISH), FISH-SP
Device

Morris Innovative, Inc.

Bloomington, IN

47403

Approval for a new version of the sub-intestinal submucosa
(SIS) material (Version 2.0).

P050047/S022

2/24/12

Special

Juvèderm Hyaluronate Gel Implants

Allergan

Goleta, CA

93117

Approval for the addition of a new Precaution Statement:
“Failure to comply with these instructions could result
in needle disengagement and/or product leakage at te Luer-lock
needle hub connection.”

P060008/S046

2/22/12

Panel-Track

TAXUS Libertè Paclitaxel-Eluting Coronary Stent System
(Monorail and Over-the-Wire)

Boston Scientific Corporation

Maple Grove, MN

55311

Approval to expand the labeled indications for the TAXUS
Libertè Paclitaxel-Eluting Coronary Stent System. The
TAXUS® Libertè® Paclitaxel-Eluting Coronary Stent
System (Monorail and Over-the-Wire Systems) is indicated for
improving luminal diameter: 1) for the treatment of de novo lesions
in native coronary arteries 2.75 mm to

4.00 mm in diameter in lesions ≤ 34 mm in length; 2) for the
treatment of de novo lesions in native coronary arteries 2.25 mm
to

2.50 mm in diameter in lesions ≤ 28 mm in length; or 3) in
patients undergoing primary angioplasty to treat acute St-segment
elevation myocardial infarction, true posterior myocardial
infarction, or presumed new left bundle branch block with symptoms
of acute myocardial infarction lasting

> 20 minutes and

< 12 hours in duration.

P060029/S003

2/3/12

180-Day

ETHICON OMNEX Surgical Sealant

Ethicon, Inc.

Somerville, NJ

08876

Approval for a manufacturing site located at Ethicon LLC., in
San Lorenzo, Puerto Rico.

P070008/S024

2/24/12

135-Day

Stratos LV/LV-T Resynchronization Therapy Pacemaker
Systems

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for addition of an automated production test
process.

P070022/S026

2/9/12

180-Day

Adiana Permanent Contraception System

Hologic, Inc.

Marlborough, MA

01752

Approval for a manufacturing site located at Hologic Costa Rica
SA., in Alajuela, Costa Rica.

P080011/S009

2/24/12

Special

CooperVision Biofinity (Comfilcon A) Soft Extended Wear Contact
Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Approval for an additional density check of the lens
extraction/hydration tanks.

P080025/S022

2/10/12

180-Day

Medtronic InterStim® Therapy System

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for design and specification changes to the Model 3058
InterStim II battery.

P100023/S015

2/22/12

Panel-Track

ION™ Paclitaxel-Eluting Coronary Stent System (Monorail
and Over-The-Wire)

Boston Scientific Corporation

Maple Grove, MN

55311

Approval to expand the labeled indications for the ION™
Paclitaxel-Eluting Coronary Stent System (Monorail and
Over-The-Wire). The ION™ Stent System is indicated for
improving luminal diameter: 1) for the treatment of de novo lesions
in native coronary arteries 2.25 mm to 4.00 mm in diameter in
lesions ≤ 34 mm in length; or 2) in patients undergoing primary
angioplasty to treat acute ST-segment elevation myocardial
infarction, true posterior myocardial infarction, or presumed new
left bundle branch block with symptoms of acute myocardial
infarction lasting

> 20 minutes and

> 12 hours in duration.

P100024/S001

2/1/12

Real-Time

HER2 CISH pharmDx™ Kit

Dako Denmark A/S

Glostrup, Denmark

DK-2600

Approval for an update of the software documentation for
DakoLink software version 3.0 to DakoLink version 3.1.1.

P100027/S002

2/15/12

180-Day

INFORM HER2 Dual ISH DNA Probe Cocktail Assay

Ventana Medical Systems, Inc.

Tucson, AZ

85755

Approval for migration of the INFORM HER2 Dual ISH DNA Probe
Cocktail assay to the BenchMark Ultra Auto-stainer. The device, as
modified, will be marketed under the trade name INFORM HER2 Dual
ISH DNA Probe Cocktail assay and is indicated “for use in
determining HER2 gene status by enumeration of the ratio of the
HER2 gene to Chromosome 17.

The HER2 and Chromosome 17 probes are detected using two color
chromogenic in situ hybridization (ISH) in formalin-fixed,
paraffin-embedded human breast cancer tissue specimens following
staining on Ventana BenchMark XT automated slide stainers (using
NexES software), or on Ventana BenchMark ULTRA automated slide
stainer (using VSS software), by light microscopy. The INFORM HER2
Dual ISH DNA Probe Cocktail is indicated as an aid in the
assessment of patients for whom HERCEPTIN (trastuzumab) treatment
is being considered.

This product should be interpreted by a qualified reader in
conjunction with histological examination, relevant clinical
information, and proper controls. This reagent is intended for
in vitro diagnostic (IVD) use.”

30-Day Notices (135 Day Supplement was not
required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P780007/S047 2/10/12	Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Additional duplicate dry lines.
P780007/S048 2/9/12	Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Addition of a new microbial air sampler and description for bioburden monitoring of the clean room.
P780007/S049 2/9/12	Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Add duplicate equipment for laboratory use.
P810002/S079 2/29/12	St. Jude Medical Mechanical Heart Valve	St. Jude Medical, Inc. St. Paul, MN 55117	Change in X-ray diffraction equipment.
P810031/S042 2/3/12	Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV and Healon5 Products	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Implementation of temporary use of an autoclave at the Uppsala, Sweden facility.
P810031/S043 2/15/12	Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV and Healon5 Products	Abbott Medical Optics Incorporated Santa Ana, CA 92705	New supplier for Holders and Rods used in Ophthalmic Viscoelastic Devices.
P840064/S048 2/3/12	DISCOVISC Opthalmic Viscosurgical Devices	Alcon Laboratories, Incorporated Forth Worth, TX 76134	Change in the sterilization process.
P840064/S049 2/1/12	Discovisc Ophthalmic Viscosurgical Device and Duovisc Viscoelastic System	Alcon Laboratories, Inc. Forth Worth, TX 76134	New analytical method for residual solvents.
P850035/S034 2/27/12	SPF PLUS-Mini (60µA/W) and SpF PLUS-Mini (60µA/M) Implantable Spinal Fusion Stimulators	Biomet, Inc. Parsippany, NJ 07054	Addition of an alternate supplier of coin cell batteries.
P860057/S085 2/24/12	Carpentier Edwards Perimount Pericardial Endoprosthesis	Edwards Lifesciences, LLC Irvine, CA 92614	Automated, greater capacity mixing, storage and distribution delivery system.
P880086/S215 2/2/12	Accent Pacemaker Devices	St. Jude Medical, CRMD Sylmar, CA 91342	Alternate supplier for RF electronic assembly modules.
P890047/S036 2/3/12	Provisc Ophthalmic Viscosurgical Devices	Alcon Laboratories, Incorporated Forth Worth, TX 76134	Change in the sterilization process.
P890047/S037 2/1/12	Provisc Ophthalmic Viscosurgical Devices	Alcon Laboratories, Inc. Forth Worth, TX 76134	New analytical method for residual solvents.
P900056/S112 2/29/12	Rotablator Rotational Atherectomy System	Boston Scientific Corporation Maple Grove, MN 55311	Use of an alternate cleaning agent for the burr preparation process.
P910001/S053 2/24/12	ELCA Coronary Atherectomy Catheters	Spectranetics Corporation Colorado Springs, CO 80921	Remove redundant Quality Control inspection steps in your Fiber Draw and Fiber Re-Spooling manufacturing processes.
P910073/S100 2/29/12	Endotak Reliance S Rx IS-1, Endotak Reliance Ez IS-1, Endotak Reliance 4-Site Ez, Endotak Reliance 4-Site Rx Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P910077/S118 2/29/12	Endotak SQ Array XP Subcutaneous Lead	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P930014/S057 2/16/12	AcrySof Intraocular Lenses	Alcon Laboratories, Inc. Forth Worth, TX 76134	Add a molding system.
P930038/S070 2/15/12	Angio-Seal Vascular Closure Device	St. Jude Medical St. Paul, MN 55114	Removal of a component cleaning step.
P950029/S065 2/2/12	Reply/Esprit SR and DR	Sorin CRM USA, Inc. Plymouth, MN 55441	Additional oven, an updated cleaning process, and an update to the rework process.
P950029/S066 2/16/12	Reply/Esprit SR and DR Pacemaker	ELA Medical, Inc. Plymouth, MN 55441	Clean room layout modifications of Saluggia, Italy plant.
P960004/S050 2/29/12	Thinline II Sterox, Fineline II Sterox, Fineline II Sterox Ez Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P960006/S032 2/29/12	Flextend Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P960013/S070 2/23/12	Optisense Lead Tubing	St. Jude Medical, Inc. Sylmar, CA 91342	Eliminate a priming process.
P960042/S034 2/24/12	SLS Spectranetics Laser Sheaths	Spectranetics Corporation Colorado Springs, CO 80921	Remove redundant Quality Control inspection steps in your Fiber Draw and Fiber Re-Spooling manufacturing processes.
P970003/S144 2/1/12	VNS Therapy System	Cyberonics, Inc. Houston, TX 77058	Three changes to the manufacturing process for the Pulse Generator in the device.
P970003/S145 2/6/12	VNS Therapy System	Cyberonics, Inc. Houston, TX 77058	Introduction of work instructions to allow rework and replacement of components in the device.
P980016/S334 2/29/12	Intrinsic, Marquis DR/VR and Maximo DR/VR ICDs	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P980016/S337 2/29/12	DR Models (Secura, Maximo II, Protecta, Protecta XT)	Medtronic, Inc. Mounds View, MN 55112	Approval for four manufacturing changes: 1) RF Module Solder Flux Clean Addition; 2) Flux Inspection Change; 3) Radio Frequency Device Test Update; and 4) a Manufacturing Site Move for 8-pin filters.
P980035/S257 2/29/12	Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa Advisa DR, EnRhythm and Relia IPGs	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P980040/S038 2/29/12	TECNIS 1-Piece Lens and TECNIS Multifocal 1-Piece Lens	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Implement a software and hardware upgrade to the equipment used to measure optical properties of intra- ocular lenses.
P980049/S069 2/2/12	Paradym VR and DR	Sorin CRM USA, Inc. Plymouth, MN 55441	Additional oven, an updated cleaning process, and an update to the rework process.
P980049/S070 2/16/12	Paradym VR & DR ICD/CRT-D, Isoline 2CR and 2CT Leads	Sorin CRM USA, Inc. Plymouth, MN 55441	Clean room layout modifications of Saluggia, Italy plant.
P990001/S100 2/29/12	Vitatron IPGs	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P000040/S022 2/14/12	Genesys HTA System	Boston Scientific Corporation Marlborough, MA 01752	Addition of a new supplier in the manufacturing process.
P000040/S023 2/29/12	Genesys HTA System	Boston Scientific Corporation Marlborough, MA 01752	New supplier of several components of the control unit subassemblies.
P000044/S029 2/23/12	VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator	Ortho Clinical Diagnostics, Inc. Rochester, NY 14626	Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P010012/S279 2/29/12	Easytrak 2 LV-1 and IS-1, Easytrak 3 LV-1 and IS-1, Acuity Spiral Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P010015/S152 2/29/12	Consulta and Syncra CRT-Ps	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P010021/S022 2/23/12	VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator	Ortho Clinical Diagnostics, Inc. Rochester, NY 14626	Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P010031/S287 2/29/12	InSync III Marquis and InSync Maximo ICDs	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P010031/S290 2/29/12	CRT-D ICD Models (Consulta, Maximo II, Protecta, Protecta XT)	Medtronic, Inc. Mounds View, MN 55112	Approval for four manufacturing changes: 1) RF Module Solder Flux Clean Addition; 2) Flux Inspection Change; 3) Radio Frequency Device Test Update; and 4) a Manufacturing Site Move for 8-pin filters.
P020030/S009 2/16/12	Stelid II BFT/BJF/Stelix BR/Stelix II BRF Endocardial Pacing Leads	ELA Medical, Inc. Plymouth, MN 55441	Clean room layout modifications of Saluggia, Italy plant.
P020036/S022 2/6/12	S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System	Cordis Corporation Miami Lakes, FL 33014	Use of new equipment for the UV bonding process.
P020047/S044 2/21/12	Multi-Link 8 Coronary Stent System	Abbott Vascular, Inc. Temecula, CA 92591	Modification of a marker alignment template; and a change to the in-process acceptance criteria for one balloon length size.
P030017/S126 2/17/12	Precision Spinal Cord Stimulator (SCS) System	Boston Scientific Corporation Valencia, CA 91355	Changes to the nickel strip welding process at the battery terminals for the device.
P030017/S127 2/17/12	Precision Spinal Cord Stimulator (SCS) System	Boston Scientific Corporation Valencia, CA 91355	Changes to the nickel strip welding process to the kovar tabs for the device.
P030017/S128 2/29/12	Precision Spinal Cord Stimulation (SCS) System	Boston Scientific Corporation Valencia, CA 91355	Addition of clarifications to the existing visual inspection criteria for the feedthrough component of the Implantable Pulse Generator (IPG).
P030024/S018 2/23/12	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	Ortho Clinical Diagnostics, Inc. Rochester, NY 14626	Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P030026/S025 2/23/12	VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator	Ortho Clinical Diagnostics, Inc. Rochester, NY 14626	Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P030028/S003 2/3/12	Artisan-Verisyse Myopia Phakic IOL	OPHTEC, USA, Inc. Boca Raton, fL 33487	Change in the Poly-methyl methacrylate (PMMA) material.
P030035/S093 2/2/12	Anthem CRT-P Devices	St. Jude Medical, CRMD Sylmar, CA 91342	Alternate supplier for RF electronic assembly modules.
P030047/S023 2/6/12	PRECISE OTW, PRECISE RX and PRECISE PRO RX Nitinol Stent System	Cordis Corporation Miami Lakes, FL 33014	Use of new equipment for the UV bonding process.
P040002/S036 2/15/12	AFX Endovascular AAA System	Endologix, Inc. Irvine, CA 92618	Change to your ePTFE graft manufacturing process.
P040004/S008 2/3/12	ADVIA Centaur HBc Total Assay	Siemens Healthcare Diagnostic E. Walpole, MA 02032	Adding an in-process step to the preparation of the labeled antigen.
P040008/S002 2/8/12	VIDAS TOTAL PSA (TPSA)	BioMèrieux, Inc. Hazelwood, MO 63042	Add an alternate supplier of the critical component Solid Phase Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA products.
P040020/S039 2/16/12	AcrySof ReSTOR Intraocular Lenses	Alcon Laboratories, Inc. Forth Worth, TX 76134	Add a molding system.
P040037/S040 2/6/12	Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin	W. L. Gore & Associates, Inc. Flagstaff, AZ 86001	Software modifications to the stent winding machine and incorporation of a barcode scanner.
P040037/S041 2/6/12	Gore VIABAHN Endoprosthesis	W.L. Gore & Associates, Inc. Flagstaff, AZ 86001	Temperature change in the device loading process.
P040045/S031 2/9/12	VISTAKON (senoficon A) Brand Contact Lenses	Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256	Use of a different clarifying filter for senofilcon A monomer mixing during manufacturing.
P040048/S016 2/10/12	Trilogy AB Acetabular System	Zimmer, Inc. Warsaw, IN 46580	Use of new labeling software.
P050046/S013 2/29/12	Acuity Steerable Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the bacterial endotoxin sampling plan.
P050047/S021 2/23/12	Juvèderm Hyaluronate Gel Implants	Allergan Goleta, CA 93117	Review of the annual revalidation of the Juvèderm sterilization cycle, and the qualification of a new sterilizer.
P060008/S084 2/15/12	TAXUS Liberte Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Modification of water system monitoring.
P060027/S036 2/2/12	Paradym CRT-D	Sorin CRM USA, Inc. Plymouth, MN 55441	Additional oven, an updated cleaning process, and an update to the rework process.
P060027/S037 2/16/12	Paradym CRT, Situs OTW Leads	ELA Medical, Inc. Plymouth, MN 55441	Clean room layout modifications of Saluggia, Italy plant.
P060037/S016 2/10/12	NexGen LPS-Flex/LPS-Mobile Bearing Knee	Zimmer, Inc. Warsaw, IN 46580	Use of new labeling software.
P080008/S001 2/8/12	VIDAS FREE PSA (FPSA)	BioMèrieux, Inc. Hazelwood, MO 63042	Add an alternate supplier of the critical component Solid Phase Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA products.
P080010/S007 2/29/12	SENSAR 1-Piece Lens and TECNIS Multifocal Lens	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Implement a software and hardware upgrade to the equipment used to measure optical properties of intra- ocular lenses.
P080011/S007 2/23/12	Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Change in the frequency of sanitization of the inspection trays used in the automated wet line inspection process.
P080011/S008 2/23/12	Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Change in the storage conditions for lenses awaiting automated wet line inspection.
P080011/S010 2/29/12	Biofinity (Comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Installation of a duplicate autoclave.
P090013/S050 2/29/12	Revo MRI IPGs	Medtronic, Inc. Mounds View, MN 55112	Reduction in line testing sample size for a component.
P100010/S014 2/9/12	Arctic Front Cardiac CryoAblation Catheter	Medtronic CryoCath LP Pointe Claire, Quebec, Canada H9R 5Z8	Raw material change to a component of the device.
P100021/S013 2/29/12	Endurant Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Change to mandrel material.
P100023/S034 2/15/12	ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Modification of water system monitoring.
P100029/S010 2/6/12	Trifecta Valve	St. Jude Medical, Inc. St. Paul, MN 55117	Changes to include: 1) An alternate electropolishing method; 2) semi-automation of stent rotation; and 3) change in fixture material.
P100041/S005 2/17/12	Edwards Sapien Transcatheter Heart Valve	Edwards Lifesciences, LLC Irvine, CA 92614	Use of a new cleanroom and changes to crimper molds.
P110019/S010 2/21/12	XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems	Abbott Vascular, Inc. Temecula, CA 92591	Modification of a marker alignment template; and a change to the in-process acceptance criteria for one balloon length size.
P110022/S003 2/27/12	Elecsys® Anti-HBc IgM on cobas e 601	Roche Diagnostics Corporation Indianapolis, IN 46250	Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110022/S004 2/27/12	Elecsys® Anti-HBc IgM on cobas e 601	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110022/S005 2/27/12	Elecsys® Anti-HBc IgM on cobas e 601	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S003 2/27/12	Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170	Roche Diagnostics Corporation Indianapolis, IN 46250	Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S004 2/27/12	Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S005 2/27/12	Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S003 2/27/12	Elecsys® Anti-HBc IgM on cobas e 411	Roche Diagnostics Corporation Indianapolis, IN 46250	Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S004 2/27/12	Elecsys® Anti-HBc IgM on cobas e 411	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S005 2/27/12	Elecsys® Anti-HBc IgM on cobas e 411	Roche Diagnostics Corporation Indianapolis, IN 46250	Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.

APPLICATION NUMBER / DATE of
APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, &
ZIP

DEVICE DESCRIPTION /
INDICATIONS

P780007/S047

2/10/12

Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Additional duplicate dry lines.

P780007/S048

2/9/12

Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Addition of a new microbial air sampler and description for
bioburden monitoring of the clean room.

P780007/S049

2/9/12

Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Add duplicate equipment for laboratory use.

P810002/S079

2/29/12

St. Jude Medical Mechanical Heart Valve

St. Jude Medical, Inc.

St. Paul, MN

55117

Change in X-ray diffraction equipment.

P810031/S042

2/3/12

Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD),
Healon, Healon GV and Healon5 Products

Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Implementation of temporary use of an autoclave at the Uppsala,
Sweden facility.

P810031/S043

2/15/12

Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD),
Healon, Healon GV and Healon5 Products

Abbott Medical Optics Incorporated

Santa Ana, CA

92705

New supplier for Holders and Rods used in Ophthalmic
Viscoelastic Devices.

P840064/S048

2/3/12

DISCOVISC Opthalmic Viscosurgical Devices

Alcon Laboratories, Incorporated

Forth Worth, TX

76134

Change in the sterilization process.

P840064/S049

2/1/12

Discovisc Ophthalmic Viscosurgical Device and Duovisc
Viscoelastic System

Alcon Laboratories, Inc.

Forth Worth, TX

76134

New analytical method for residual solvents.

P850035/S034

2/27/12

SPF PLUS-Mini

(60µA/W) and SpF PLUS-Mini (60µA/M) Implantable Spinal
Fusion Stimulators

Biomet, Inc.

Parsippany, NJ

07054

Addition of an alternate supplier of coin cell batteries.

P860057/S085

2/24/12

Carpentier Edwards Perimount Pericardial Endoprosthesis

Edwards Lifesciences, LLC

Irvine, CA

92614

Automated, greater capacity mixing, storage and distribution
delivery system.

P880086/S215

2/2/12

Accent Pacemaker Devices

St. Jude Medical, CRMD

Sylmar, CA

91342

Alternate supplier for RF electronic assembly modules.

P890047/S036

2/3/12

Provisc Ophthalmic Viscosurgical Devices

Alcon Laboratories, Incorporated

Forth Worth, TX

76134

Change in the sterilization process.

P890047/S037

2/1/12

Provisc Ophthalmic Viscosurgical Devices

Alcon Laboratories, Inc.

Forth Worth, TX

76134

New analytical method for residual solvents.

P900056/S112

2/29/12

Rotablator Rotational Atherectomy System

Boston Scientific Corporation

Maple Grove, MN

55311

Use of an alternate cleaning agent for the burr preparation
process.

P910001/S053

2/24/12

ELCA Coronary Atherectomy Catheters

Spectranetics Corporation

Colorado Springs, CO

80921

Remove redundant Quality Control inspection steps in your Fiber
Draw and Fiber Re-Spooling manufacturing processes.

P910073/S100

2/29/12

Endotak Reliance S Rx IS-1, Endotak Reliance Ez IS-1, Endotak
Reliance 4-Site Ez, Endotak Reliance 4-Site Rx Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P910077/S118

2/29/12

Endotak SQ Array XP Subcutaneous Lead

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P930014/S057

2/16/12

AcrySof Intraocular Lenses

Alcon Laboratories, Inc.

Forth Worth, TX

76134

Add a molding system.

P930038/S070

2/15/12

Angio-Seal Vascular Closure Device

St. Jude Medical

St. Paul, MN

55114

Removal of a component cleaning step.

P950029/S065

2/2/12

Reply/Esprit SR and DR

Sorin CRM USA, Inc.

Plymouth, MN

55441

Additional oven, an updated cleaning process, and an update to
the rework process.

P950029/S066

2/16/12

Reply/Esprit SR and DR Pacemaker

ELA Medical, Inc. Plymouth, MN

55441

Clean room layout modifications of Saluggia, Italy plant.

P960004/S050

2/29/12

Thinline II Sterox, Fineline II Sterox, Fineline II Sterox Ez
Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P960006/S032

2/29/12

Flextend Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P960013/S070

2/23/12

Optisense Lead Tubing

St. Jude Medical, Inc.

Sylmar, CA

91342

Eliminate a priming process.

P960042/S034

2/24/12

SLS Spectranetics Laser Sheaths

Spectranetics Corporation

Colorado Springs, CO

80921

Remove redundant Quality Control inspection steps in your Fiber
Draw and Fiber Re-Spooling manufacturing processes.

P970003/S144

2/1/12

VNS Therapy System

Cyberonics, Inc.

Houston, TX

77058

Three changes to the manufacturing process for the Pulse
Generator in the device.

P970003/S145

2/6/12

VNS Therapy System

Cyberonics, Inc.

Houston, TX

77058

Introduction of work instructions to allow rework and
replacement of components in the device.

P980016/S334

2/29/12

Intrinsic, Marquis DR/VR and Maximo DR/VR ICDs

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P980016/S337

2/29/12

DR Models (Secura, Maximo II, Protecta, Protecta XT)

Medtronic, Inc.

Mounds View, MN

55112

Approval for four manufacturing changes: 1) RF Module Solder
Flux Clean Addition;

2) Flux Inspection Change; 3) Radio Frequency Device Test Update;
and 4) a Manufacturing Site Move for 8-pin filters.

P980035/S257

2/29/12

Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa Advisa DR,
EnRhythm and Relia IPGs

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P980040/S038

2/29/12

TECNIS 1-Piece Lens and TECNIS Multifocal 1-Piece Lens

Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Implement a software and hardware upgrade to the equipment used
to measure optical properties of intra- ocular lenses.

P980049/S069

2/2/12

Paradym VR and DR

Sorin CRM USA, Inc.

Plymouth, MN

55441

Additional oven, an updated cleaning process, and an update to
the rework process.

P980049/S070

2/16/12

Paradym VR & DR ICD/CRT-D, Isoline 2CR and 2CT Leads

Sorin CRM USA, Inc.

Plymouth, MN

55441

Clean room layout modifications of Saluggia, Italy plant.

P990001/S100

2/29/12

Vitatron IPGs

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P000040/S022

2/14/12

Genesys HTA System

Boston Scientific Corporation

Marlborough, MA

01752

Addition of a new supplier in the manufacturing process.

P000040/S023

2/29/12

Genesys HTA System

Boston Scientific Corporation

Marlborough, MA

01752

New supplier of several components of the control unit
subassemblies.

P000044/S029

2/23/12

VITROS Immunodiagnostic Products HBsAg Reagent Pack and
Calibrator

Ortho Clinical Diagnostics, Inc.

Rochester, NY

14626

Changing the timing of the tests in the QA release test from
sequential to concurrent, described as the Single Test.

P010012/S279

2/29/12

Easytrak 2 LV-1 and IS-1, Easytrak 3

LV-1 and IS-1, Acuity Spiral Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P010015/S152

2/29/12

Consulta and Syncra CRT-Ps

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P010021/S022

2/23/12

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and
Calibrator

Ortho Clinical Diagnostics, Inc.

Rochester, NY

14626

Changing the timing of the tests in the QA release test from
sequential to concurrent, described as the Single Test.

P010031/S287

2/29/12

InSync III Marquis and InSync Maximo ICDs

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P010031/S290

2/29/12

CRT-D ICD Models (Consulta, Maximo II, Protecta, Protecta
XT)

Medtronic, Inc.

Mounds View, MN

55112

Approval for four manufacturing changes: 1) RF Module Solder
Flux Clean Addition; 2) Flux Inspection Change; 3) Radio Frequency
Device Test Update; and 4) a Manufacturing Site Move for 8-pin
filters.

P020030/S009

2/16/12

Stelid II BFT/BJF/Stelix BR/Stelix II BRF Endocardial Pacing
Leads

ELA Medical, Inc. Plymouth, MN

55441

Clean room layout modifications of Saluggia, Italy plant.

P020036/S022

2/6/12

S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System

Cordis Corporation

Miami Lakes, FL

33014

Use of new equipment for the UV bonding process.

P020047/S044

2/21/12

Multi-Link 8 Coronary Stent System

Abbott Vascular, Inc.

Temecula, CA

92591

Modification of a marker alignment template; and a change to
the in-process acceptance criteria for one balloon length
size.

P030017/S126

2/17/12

Precision Spinal Cord Stimulator (SCS) System

Boston Scientific Corporation

Valencia, CA

91355

Changes to the nickel strip welding process at the battery
terminals for the device.

P030017/S127

2/17/12

Precision Spinal Cord Stimulator (SCS) System

Boston Scientific Corporation

Valencia, CA

91355

Changes to the nickel strip welding process to the kovar tabs
for the device.

P030017/S128

2/29/12

Precision Spinal Cord Stimulation (SCS) System

Boston Scientific Corporation

Valencia, CA

91355

Addition of clarifications to the existing visual inspection
criteria for the feedthrough component of the Implantable Pulse
Generator (IPG).

P030024/S018

2/23/12

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and
Calibrator

Ortho Clinical Diagnostics, Inc.

Rochester, NY

14626

Changing the timing of the tests in the QA release test from
sequential to concurrent, described as the Single Test.

P030026/S025

2/23/12

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and
Calibrator

Ortho Clinical Diagnostics, Inc.

Rochester, NY

14626

Changing the timing of the tests in the QA release test from
sequential to concurrent, described as the Single Test.

P030028/S003

2/3/12

Artisan-Verisyse Myopia Phakic IOL

OPHTEC, USA, Inc.

Boca Raton, fL

33487

Change in the Poly-methyl methacrylate (PMMA) material.

P030035/S093

2/2/12

Anthem CRT-P Devices

St. Jude Medical, CRMD

Sylmar, CA

91342

Alternate supplier for RF electronic assembly modules.

P030047/S023

2/6/12

PRECISE OTW, PRECISE RX and PRECISE PRO RX Nitinol Stent
System

Cordis Corporation

Miami Lakes, FL

33014

Use of new equipment for the UV bonding process.

P040002/S036

2/15/12

AFX Endovascular AAA System

Endologix, Inc.

Irvine, CA

92618

Change to your ePTFE graft manufacturing process.

P040004/S008

2/3/12

ADVIA Centaur HBc Total Assay

Siemens Healthcare Diagnostic

E. Walpole, MA

02032

Adding an in-process step to the preparation of the labeled
antigen.

P040008/S002

2/8/12

VIDAS TOTAL PSA (TPSA)

BioMèrieux, Inc.

Hazelwood, MO

63042

Add an alternate supplier of the critical component Solid Phase
Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA
products.

P040020/S039

2/16/12

AcrySof ReSTOR Intraocular Lenses

Alcon Laboratories, Inc.

Forth Worth, TX

76134

Add a molding system.

P040037/S040

2/6/12

Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with
Heparin

W. L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Software modifications to the stent winding machine and
incorporation of a barcode scanner.

P040037/S041

2/6/12

Gore VIABAHN Endoprosthesis

W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Temperature change in the device loading process.

P040045/S031

2/9/12

VISTAKON (senoficon A) Brand Contact Lenses

Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Use of a different clarifying filter for senofilcon A monomer
mixing during manufacturing.

P040048/S016

2/10/12

Trilogy AB Acetabular System

Zimmer, Inc.

Warsaw, IN

46580

Use of new labeling software.

P050046/S013

2/29/12

Acuity Steerable

Leads

Boston Scientific Corporation

St. Paul, MN

55112

Change to the bacterial endotoxin sampling plan.

P050047/S021

2/23/12

Juvèderm Hyaluronate Gel Implants

Allergan

Goleta, CA

93117

Review of the annual revalidation of the Juvèderm
sterilization cycle, and the qualification of a new
sterilizer.

P060008/S084

2/15/12

TAXUS Liberte Paclitaxel-Eluting Coronary Stent System

Boston Scientific Corporation

Maple Grove, MN

55311

Modification of water system monitoring.

P060027/S036

2/2/12

Paradym CRT-D

Sorin CRM USA, Inc.

Plymouth, MN

55441

Additional oven, an updated cleaning process, and an update to
the rework process.

P060027/S037

2/16/12

Paradym CRT, Situs OTW Leads

ELA Medical, Inc. Plymouth, MN

55441

Clean room layout modifications of Saluggia, Italy plant.

P060037/S016

2/10/12

NexGen LPS-Flex/LPS-Mobile Bearing Knee

Zimmer, Inc.

Warsaw, IN

46580

Use of new labeling software.

P080008/S001

2/8/12

VIDAS FREE PSA (FPSA)

BioMèrieux, Inc.

Hazelwood, MO

63042

Add an alternate supplier of the critical component Solid Phase
Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA
products.

P080010/S007

2/29/12

SENSAR 1-Piece Lens and TECNIS Multifocal Lens

Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Implement a software and hardware upgrade to the equipment used
to measure optical properties of intra- ocular lenses.

P080011/S007

2/23/12

Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Change in the frequency of sanitization of the inspection trays
used in the automated wet line inspection process.

P080011/S008

2/23/12

Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Change in the storage conditions for lenses awaiting automated
wet line inspection.

P080011/S010

2/29/12

Biofinity (Comfilcon A) Soft (Hydrophilic) Extended Wear
Contact Lenses

CooperVision, Inc.

Pleasanton, CA

94588

Installation of a duplicate autoclave.

P090013/S050

2/29/12

Revo MRI IPGs

Medtronic, Inc.

Mounds View, MN

55112

Reduction in line testing sample size for a component.

P100010/S014

2/9/12

Arctic Front Cardiac CryoAblation Catheter

Medtronic CryoCath LP

Pointe Claire, Quebec, Canada

H9R 5Z8

Raw material change to a component of the device.

P100021/S013

2/29/12

Endurant Stent Graft System

Medtronic Vascular

Santa Rosa, CA

95403

Change to mandrel material.

P100023/S034

2/15/12

ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent
System

Boston Scientific Corporation

Maple Grove, MN

55311

Modification of water system monitoring.

P100029/S010

2/6/12

Trifecta Valve

St. Jude Medical, Inc.

St. Paul, MN

55117

Changes to include: 1) An alternate electropolishing method; 2)
semi-automation of stent rotation; and 3) change in fixture
material.

P100041/S005

2/17/12

Edwards Sapien Transcatheter Heart Valve

Edwards Lifesciences, LLC

Irvine, CA

92614

Use of a new cleanroom and changes to crimper molds.

P110019/S010

2/21/12

XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary
Stent Systems

Abbott Vascular, Inc.

Temecula, CA

92591

Modification of a marker alignment template; and a change to
the in-process acceptance criteria for one balloon length
size.

P110022/S003

2/27/12

Elecsys® Anti-HBc IgM on cobas e 601

Roche Diagnostics Corporation

Indianapolis, IN

46250

Manufacturing process change to increase the concentration of
the Intermediate Storage Form (ISF) bulk component common to all
devices.

P110022/S004

2/27/12

Elecsys® Anti-HBc IgM on cobas e 601

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to the in- process particle concentration determination
method for the Intermediate Storage Form (ISF) bulk component
common to all devices.

P110022/S005

2/27/12

Elecsys® Anti-HBc IgM on cobas e 601

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to increase production capacity for the Intermediate
Storage Form (ISF) bulk component common to all devices.

P110025/S003

2/27/12

Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170

Roche Diagnostics Corporation

Indianapolis, IN

46250

Manufacturing process change to increase the concentration of
the Intermediate Storage Form (ISF) bulk component common to all
devices.

P110025/S004

2/27/12

Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to the in- process particle concentration determination
method for the Intermediate Storage Form (ISF) bulk component
common to all devices.

P110025/S005

2/27/12

Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to increase production capacity for the Intermediate
Storage Form (ISF) bulk component common to all devices.

P110031/S003

2/27/12

Elecsys® Anti-HBc IgM on cobas e 411

Roche Diagnostics Corporation

Indianapolis, IN

46250

Manufacturing process change to increase the concentration of
the Intermediate Storage Form (ISF) bulk component common to all
devices.

P110031/S004

2/27/12

Elecsys® Anti-HBc IgM on cobas e 411

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to the in- process particle concentration determination
method for the Intermediate Storage Form (ISF) bulk component
common to all devices.

P110031/S005

2/27/12

Elecsys® Anti-HBc IgM on cobas e 411

Roche Diagnostics Corporation

Indianapolis, IN

46250

Change to increase production capacity for the Intermediate
Storage Form (ISF) bulk component common to all devices.

Summary of PMA Originals & Supplements
Approved

Originals: 6

Supplements: 58

Summary of PMA Originals Under Review

Total Under Review: 73

Total Active: 29

Total On Hold: 44

Number Greater Than 180 Days: 2

Summary of PMA Supplements Under Review

Total Under Review: 642

Total Active: 477

Total On Hold: 165

Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received

Originals: 1

Supplements: 92

Summary of PMA Supplement PMA Approval/Denial Decision
Times

Number of Approvals: 58

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 187.4

FDA Time: 132.2 Days MFR Time: 55.2 Days

SOURCE

30-Day Notices (135 Day Supplement was not required)

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30-Day Notices (135 Day Supplement was not
required)