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
The BreathTek UBT for H pylori Kit (BreathTek UBT Kit) is |
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 |
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″ ; |
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
3) Minor dimension and tolerance changes to the mounting plate to
5) Adding an inspection step and test fixture to verify the |
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 |
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 |
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
2.50 mm in diameter in lesions ≤ 28 mm in length; or 3) in > 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
This product should be interpreted by a qualified reader in |
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 |
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; |
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