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 |
---|---|---|---|
P090002 6/13/11 |
Pinnacle® CoMplete® Acetabular Hip System | DePuy Orthopaedics, Inc.
Warsaw, IN 46581 |
Approval for the Pinnacle® CoMplete® Acetabular Hip System. This device is indicated for:
The Pinnacle® CoMplete® Acetabular Hip System is a single
disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) arthritis.
Pinnacle®” CoMplete® Acetabular Hip System’s inserts
intended for use with DePuy’s femoral and acetabular components and inner diameters.
|
P100027 6/14/11 |
INFORM® HER2 Dual ISH DNA Probe Cocktail | Ventana Medical Systems, Inc.
Tucson, AZ 85755 |
Approval for the INFORM® HER2 Dual ISH DNA Probe Cocktail. This device is indicated for:
The INFORM® HER2 Dual ISH DNA Probe Cocktail is intended for
hybridization (ISH) in formalin-fixed. paraffin-embedded human
NeXES software), by light microscopy. The I NFORM® H ER2 Dual (trastuzumab) treatment is being considered.
This product should be interpreted by a qualified reader in
This reagent is intended for in vitro diagnostic (IVD) |
P100031 6/22/11 |
Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer |
Roche Diagnostics Corporation
Indianapolis, IN 46250 |
Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium-heparin, sodium-citrate, K 2 -EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay’s performance has not been established for the monitoring HBV disease or therapy. The electro- chemiluminescence immunoassay “ECLIA” is intended for use on the MODULAR ANALYTICS EI70 Immunoassay Analyzer. The Elecsys Preci-Control Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the MODULAR ANALYTICS E170 immunoassay analyzer. |
P100032 6/27/11 |
Elecsys® Anti-HBc Immunoassay and
Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010 Immunoassay Analyzer |
Roche Diagnostics Corporation
Indianapolis, IN 46250 |
Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010
Immunoassay Analyzer. This device is indicated for the in |
APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP |
DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P820060/S027
6/10/11 180-Day |
AxSYM AFP | Abbott Laboratories Abbott Park, IL
60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
P830061/S061
6/16/11 135-Day |
CapSure, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+ Leads |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P830061/S062
6/27/11 135-Day |
CapSure SP Novus Leads, CapSure, CapSure Sense Leads, Vitatron Excellence PS+, Vitatron Crystalline |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P830063/S006
6/17/11 Real-Time |
PRISMAFLEX TPE 2000 Set | Gambro Renal Products
Lakewood, CO 80401 |
Approval for modifications to the Gambro Prisma TPE 2000 Set with Plasmafilter PF 2000N to permit the use of the plasmafilter with the Gambro PRISMAFLEX System. The device, as modified, will be marketed under the trade name PRISMAFLEX TPE 2000 Set and is indicated for therapeutic plasmapheresis. |
P850089/S074
6/16/11 135-Day |
CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, Vitatron Impulse II Leads |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P850089/S075
6/27/11 135-Day |
CapSure Z Novus Leads, CapSure SP Novus Leads, CapSure, Vitatron Excellence, Vitatron Excellence SS+, Vitatron Impluse II, CapSure SP Z Leads |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P880047/S015
6/17/11 Real-Time |
GYNECARE INTERCEED® Absorbable Adhesion Barrier | Ethicon, Inc. Somerville, NJ
08876 |
Approval for a larger INTERCEED® product that measures 5”x6” in size. The device, as modified, is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved. |
P880086/S204
6/8/11 Real-Time |
Sustain XL Family of Pacemakers | St. Jude Medical, Inc.
Sunnyvale, CA 94086 |
Approval for the new Sustain XL Pacemaker Models, predicated off
the Victory/Zephyr family of pacemaker. The device, as modified,
trade name Sustain XL DR/SR and Sustain XL DC/SC and is indicated Indications and Usage
• Implantation of Sustain™ pulse generators is indicated • Syncope • Presyncope • Fatigue • Disorientation • Or any combination of those symptoms.
Rate-Modulated Pacing is indicated for patients • Sick sinus syndrome • Chronic, symptomatic second- and third-degree AV block • Recurrent Adams-Stokes syndrome
• Symptomatic bilateral bundle branch block when
Atrial Pacing is indicated for patients with sinus node intraventricular conduction systems.
Ventricular Pacing is indicated for patients with significant
• Normal sinus rhythm with only rare episodes of A-V block or • Chronic atrial fibrillation • Severe physical disability.
AF Suppression (Models PM2134 and PM2136 only) is indicated for |
P890003/S218
6/16/11 135-Day |
CapSure VDD2, Brilliant S+ Leads | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P890003/S219
6/27/11 135-Day |
Prodigy lPG, Leads Wrench Kit, Leads Service Kit, Vitatron Brilliant S+, Capsure VDD Leads, Connector Port Pin-Plug |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P890055/S034
6/21/11 Special |
MedStream Programmable Infusion System | Codman & Shurtleff, Incorporated
Raynham, MA 02767 |
Approval to add a warning statement to the Instructions for Use. |
P900061/S100
6/27/11 135-Day |
Ace Header, Patch Lead, Lead End Pin Cup | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes.` |
P910007/S023
6/8/11 180-Day |
ARCHITECT Total PSA | Abbott Laboratories Abbott Park, IL
60064 |
Approval for manufacturing site located at Abbott Ireland Diagnostic Division in Sligo, Ireland. |
P910007/S025
6/10/11 180-Day |
AxSYM Total PSA | Abbott Laboratories Abbott Park, IL
60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
P910007/S026
6/22/11 180-Day |
ARCHITECT Total PSA | Abbott Laboratories
Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland. |
P910023/S257
6/21/11 180-Day |
Cadence/Current/ Fortify Family of ICDs | St. Jude Medical
Sunnyvale, CA 94086 |
Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices. |
P910023/S266
6/28/11 180-Day |
Current Accel VR, DR ICDs and Fortify VR, DR ICDs | St. Jude Medical
Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P910073/S089
6/14/11 135-Day |
Reliance IS-1 Family of Leads | Boston Scientific Corporation
St. Paul, MN 55112 |
Approval for acceptance of an enhancement to the insulation and tri-lumen bond process, to include an upgrade of the bonding equipment and additional acceptance activity inspections to verify an adequate bond which will prevent fluid leakage. |
P910077/S115
6/21/11 Real-Time |
LATITUDE Paceart Integration System | Boston Scientific Corporation
St. Paul, MN 55112 |
Approval for modifications to the LATITUDE Paceart Integration (LPI) software, Model 6472 v1.01. |
P920015/S074
6/27/11 135-Day |
IS-l Port Pin Plug, Y Adaptor Kit, Lead Adaptor, Sprint Lead, Sprint Quattro Lead, Sprint Quattro Secure Lead, Subcutaneous
Defibrillation Lead, Transvene SVC Lead, Tunneling Tool, Lead, Sprint Quattro Single Coil |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P930039/S049
6/16/11 135-Day |
CapSure Fix, CapSure Fix NovusSureFix Leads | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P930039/S050
6/27/11 135-Day |
CapSureFix Novus Lead, SureFix Novus Lead, CapSureFix Lead, Vitatron Pirouet Lead, Vitatron Crystalline Actfix Lead |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P950024/S029
6/27/11 135-Day |
CapSure EPI Unipolar Lead, CapSure EPI Bipolar Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P960007/S020
6/13/11 135-Day |
TransCyte Human Fibroblast-Derived Temporary Skin Substitute |
Advanced BioHealing, Inc.
La Jolla, CA 92037 |
Approval for modification of the automated and manual cell expansion trypsinization processes for manufacturing TransCyte. |
P960013/S065
6/28/11 180-day |
Tendril STS Lead | St. Jude Medical
Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P970004/S087
6/9/11 180-Day |
Medtronic InterStim II Neurostimulator | Medtronic, Inc.
Minneapolis, MN 55432 |
Approval for design and specification changes to the Model 3058 InterStim II battery. |
P970004/S116
6/8/11 Special |
Medtronic InterStim® Therapy for Urinary Control | Medtronic, Inc.
Minneapolis, MN 55432 |
Approval for the addition of two precaution statements to the labeling of the Model 3037 patient programmer. |
P970021/S030
6/13/11 135-Day |
GYNECARE THERMACHOICE III Uterine Balloon Therapy System | ETHICON, Inc. Somerville, NJ
08876 |
Approval for changes to the catheter balloon measurement process. |
P970051/S069
6/3/11 Real-Time |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for a modified version of the external CP810 sound processor main BTE module (approved under P970051/S049), called Build Standard D, which is primarily intended to allow for repair of the processor. |
P980007/S016
6/10/11 180-Day |
AxSYM Free PSA | Abbott Laboratories Abbott Park, IL
60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland. |
P980007/S017
6/22/11 180-Day |
ARCHITECT Free PSA | Abbott Laboratories
Abbott Park, IL 60064 |
Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland. |
P980016/S288
6/27/11 135-Day |
Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, CapSure Lead, EnTrust ICD Family, Virtuoso ICD Family, Maximo II lCD, Secura lCD, Virtuoso ICD |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P980035/S211
6/27/11 135-Day |
Sigma IPG Family, Medtronic 360 IPG Series, EnRhythm lPG, AT500 Systems, Adapta/ Versa/Sensia lPG, Relia IPG |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P980035/S227
6/2/11 Real-Time |
Adapta, Versa, Sensia and Relia Implantable Pulse Generators |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an increase in gold thickness on XE263 accelerometer. |
P980050/S059
6/27/11 135-Day |
CS-SVC Transvene Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P990001/S086
6/27/11 135-Day |
C-Series IPG, T-Series IPG | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P990056/S011
6/20/11 135-Day
|
Elecsys total PSA Immunoassay | Roche Diagnostics Corporation
Indianapolis, IN 46250 |
Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility. |
P000012/S027
6/27/11 135-Day |
COBAS AMPLICOR HCV Test, COBAS Ampliprep/COBAS AMPLICOR HCV Test |
Roche Molecular Systems, Inc.
Pleasanton, CA 94588 |
Approval for changes to the test methods 1) magnetic susceptibility; and 2) surface area of the Tosylated magnetic beads used by the vendor. |
P000027/S009
6/20/11 135-Day |
Elecsys free PSA Immunoassay | Roche Diagnostics Corporation
Indianapolis, IN 46250 |
Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility. |
P000053/S036
6/13/11 135-Day |
AMS 800 Artificial Urinary Sphincter | American Medical Systems, Inc.
Minnetonka, MN 55343 |
Approval for a new component mold. |
P000053/S037
6/24/11 180-Day |
AMS Sphincter 800® Urinary Prosthesis | American Medical Systems, Inc.
Minnetonka, MN 55343 |
Approval for modifications to the design specifications and manufacturing process of the AMS 800 Control Pump, a component of the AMS Sphincter 800® Urinary Prosthesis. |
P010015/S111
6/16/11 135-Day |
Attain Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P010015/S112
6/27/11 135-Day |
InSync III CRT-P, Attain OTW Lead, Attain Bipolar OTW Lead, Attain LV Lead |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P010031/S242
6/27/11 135-Day |
InSync II Marquis lCD, InSync III Marquis lCD, InSync Marquis lCD, InSync Sentry ICD family, InSync Maximo ICD family, Concerto CRT-D, Maximo II CRT-D, Consulta CRT-D, Concerto II CRT-D |
Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P010050/S011
6/24/11 180-Day |
IMMULITE® 2000 HBsAG Confirmatory Kit | Siemens Healthcare Diagnostics
Norwood, MA 02062 |
Approval for an automated means of confirmation testing on-board the IMMULITE® 2000 immunoassay analyzer. The device, as modified, will be marketed under the trade name IMMULITE® 2000 HBsAg Confirmatory Kit and is indicated for:
IMMULITE 2000 HBsAg Confirmatory is intended for in vitro
IMMULITE 2000 analyzers in conjunction with the IMMULITE 2000
the confirmation of the presence of hepatitis B surface antigen |
P020018/S037
6/7/11 180-Day |
Zenith Flex® AAA Endovascular Graft | Cook, Inc.
Bloomington, IN 47402 |
Approval to add the Zenith Spiral-Z® AAA Endovascular Graft Iliac Leg to the
existing Zenith Flex® AAA Endovascular Graft product line. The
marketed under the trade name Zenith Spiral-Z® AAA
indicated for use with the Zenith AAA Endovascular Graft family of
secondary procedure in patients who have adequate iliac/femoral
required introduction systems. The graft is used in combination |
P020047/S029
6/16/11 135-Day |
Multi-Link Vision, Multi-Link Mini-Vision OTW and RX, Multi-Link 8, Multi-Link 8LL, Multi-Link 8 SV Coronary Stent Systems |
Abbott Vascular, Inc.
Temecula, CA 92590 |
Approval to remove a redundant receiving inspection test. |
P030009/S054
6/9/11 Real-Time |
Integrity Coronary Stent System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for addition of labeling regarding simultaneous use of the Integrity RX stent system with either another Integrity RX stent system, or with a Sprinter Legend RX balloon dilation catheter. In addition, approval to revise the MRI compatibility information in the labeling. |
P030035/S084
6/28/11 180-Day |
Promote Accel
CRT-D |
St. Jude Medical
Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P030036/S027
6/27/11 135-Day |
SelectSecure Lead, Sleeve Kit | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P030054/S181
6/21/11 180-Day |
Epic HF/Atlas+HF/ Promote/Unify Family of CRT-Ds | St. Jude Medical
Sunnyvale, CA 94086 |
Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices. |
P030054/S191
6/28/11 180-Day |
Quickflex µ Leads, Unify CRT-Ds | St. Jude Medical
Sylmar, CA 91342 |
Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico. |
P040020/S029
6/30/11 180-Day |
AcrySof IQ ReSTOR IOL | Alcon Research, Ltd. Fort Worth, TX
76134 |
Approval for a manufacturing site located at Alcon Laboratories Ireland Ltd. in Cork, Ireland. |
P040048/S014
6/2/11 Special |
Trilogy AB® Acetabular System | Zimmer, Inc.
Warsaw, IN 46581 |
Approval for adding information about MRI safety to the package insert and patient labeling. |
P050011/S002
6/17/11 135-Day |
ADEPT Adhesion Reduction Solution (4% Icodextrin) | Baxter Healthcare Corporation
McGaw Park, IL 60085 |
Approval to implement the assay for detecting the amount of peptidoglycan (PG) in the Icodextrin Active Pharmaceutical Ingredient (API). |
P050012/S037
6/3/11 Real-Time |
DexCom Seven and Seven Plus Continuous Glucose Monitoring Systems |
DexCom, Inc.
San Diego, CA 92121 |
Approval for replacement of an obsolete LCD in the receiver assembly with a similar component and minor modifications to the receiver firmware to accommodate the new hardware. |
P050028/S011
6/24/11 135-Day |
COBAS AmpliPrep/ COBAS TaqMan HBV Test | Roche Molecular Systems, Inc.
Pleasanton, CA 94588 |
Approval for an addition of a second sintering oven for the manufacture of the bulk Magnetic Glass Particle (MGP) raw material used in the production of the MPG reagent. |
P050042/S012
6/1/11 180-Day |
ARCHITECT Anti-HCV | Abbott Laboratories
Irving, TX 75038 |
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore. |
P050046/S009
6/29/11 135-Day |
ACUITY™ Steerable Stylet Accessory | Boston Scientific Corporation
St. Paul, MN 55112 |
Approval for acceptance of a change to relocate a sensor on wire grinding equipment and formalize inspections as acceptance activities. |
P050051/S012
6/1/11 180-Day |
ARCHITECT AUSAB | Abbott Laboratories
Irving, TX 75038 |
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore. |
P060003/S005
6/9/11 Real-Time |
Abbott AxSYM AUSAB | Abbott Laboratories
Abbott Park, IL 60064 |
Approval for changes to the manufacturing and quality control testing for AxSYM AUSAB Calibrators, Controls, and Reagents. |
P060007/S014
6/1/11 180-Day |
ARCHITECT HBsAg/
Confirmatory |
Abbott Laboratories
Irving, TX 75038 |
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore. |
P060033/S064
6/2/11 180-Day |
Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular
Santa Rosa, CA 95403 |
Approval for changes to the instructions for use (with the latest available follow-up clinical data from the Endeavor clinical trial programs). |
P060035/S008
6/1/11 180-Day |
ARCHITECT CORE-M | Abbott Laboratories
Irving, TX 75038 |
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore. |
P060039/S023
6/16/11 135-Day |
Attain StarFix Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P060039/S024
6/27/11 135-Day |
Attain StarFix Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P070015/S058
6/16/11 135-Day |
XIENCE V and Promus Everolimus Eluting Coronary Stent Systems |
Abbott Vascular, Inc.
Temecula, CA 92590 |
Approval to remove a redundant receiving inspection test. |
P070026/S001
6/7/11 180-Day |
Ceramax Ceramic Total Hip System | DePuy, Inc.
Warsaw, IN 46581 |
Approval of post-approval study protocol. |
P080004/S007
6/15/11 Real-Time |
iSert® | Hoya Surgical Optics, Inc.
Chino Hills, CA 91709 |
Approval for packaging changes to the Model PY-60AD. The device, as modified, will be marketed under the trade name iSert® Model PY-60ADC and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed. |
P080006/S021
6/27/11 135-Day |
Attain Ability Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P080023/S008
6/1/11 180-Day |
ARCHITECT CORE | Abbott Laboratories
Irving, TX 75038 |
Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore. |
P080025/S008
6/10/11 Special |
Medtronic® InterStim® Therapy System | Medtronic, Inc. Minneapolis, MN
55432 |
Approval for changes to the labeling for the 3037 Patient Programmer to add new precautions relating to modification of the device and the effect of electromagnetic interference (EMI) on the patient programmer’s ability to communicate with the neurostimulator. |
P080032/S005
6/10/11 180-Day |
Alair® Bronchial Thermoplasty System | Asthmatx, Inc.
Sunnyvale, CA 94089 |
Approval for a manufacturing site located at Asthmatx, Inc. in Sunnyvale, California. |
P080032/S007
6/21/11 180-Day |
Alair® Bronchial Thermoplasty System | Boston Scientific Corporation
Sunnyvale, CA 94089 |
Approval of the post approval study protocol. |
P090013/S010
6/16/11 135-Day |
CapSure Fix MRI Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray. |
P090013/S011
6/27/11 135-Day |
Revo IPG, Revo MRI Lead | Medtronic, Inc.
Mounds View, MN 55112 |
Approval for the change of the cleaning control area and the associated processes. |
P100010/S010
6/28/11 Real-Time |
Arctic Front® Cardiac Cryoablation Catheter | Medtronic CryoCath, LP
Eagan, MN 55123 |
Approval for changes to the labeling to include compatibility for use with the Medtronic Achieve Mapping Catheter. |
P100018/S001
6/27/11 180-Day |
Pipeline Embolic Device | Chestnut Medical Technologies, Inc.
Meno Park, CA 94025 |
Approval of post- approval study protocol. |
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 |
---|---|---|---|
N18033/S056
6/10/11 |
VISTAKON (etafilcon A) and (senofilcon) Brand Contact Lenses |
Vision Care, Inc.
Jacksonville, FL 32256 |
Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer. |
N18033/S057
6/8/11 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Evaluation of the automation of the repackaging activities conducted by a qualified supplier. |
N18033/S058
6/16/11 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses. |
N18033/S059
6/22/11 |
VISTAKON (etafilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Use an electronic Raw Material Tracking System. |
P820003/S106
6/10/11 |
Disposable Cover | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P820021/S033
6/8/11 |
Vifilcon A Soft Contact Lenses for Extended Wear | CIBA VISION Corporation
Duluth, GA 30097 |
Change the Alternate Raw Material Sourcing for (Vifilcon A formulation) Soft Contact Lens Materials. |
P830060/S069
6/17/11 |
Tachy Adapter | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P830061/S065
6/10/11 |
CapSure and Vitatron Excellence+ | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P840001/S186
6/16/11 |
Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator, Synergy Family of Implantable Neurostimulators, Specify Surgical Leads, Hinged 2X4 Surgical Leads, Resume Surgical Leads, SymMix Surgical Leads,
1X8 Lead Family, Pisces Lead Family, Quadripolar Extensions, 1X8 1X8 Synergy Extensions,
Low Profile Quadripolar, Extensions, Accessories and Accessory Control Magnet |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P840001/S187
6/17/11 |
7425 Itrel 3 IPG, 7427 Synergy IPG, 7427V Synergy Versitrel IPG, 37701
RestorePrime INS, 37702 PrimeAdvanced INS, 37711 Restore INS, |
Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an ethylene oxide sterilizer system. |
P840001/S188
6/22/11 |
Intrel 3, Synergy Family | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an alternate qualified supplier for components used in the feedthrough assembly. |
P850089/S077
6/10/11 |
CapSure SP Z Leads, Vitatron Impulse, Vitatron Excellence S+, Vitratron Excellence SS+ and Vitatron Impulse II |
Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P860004/S152
6/16/11 |
Synchromed II Implantable Infusion Pumps, Intra-arterial Vascular Catheters, InDura IP Intrathecal Catheters, Intrathecal Catheters, Refill Kits, Sutureless Pump Connector Revision Kits,
Proximal Catheter Revision Kits, Distal Catheter Revision Kits, Pumps, Intraspinal Trial Kits and Programmer Power Adaptor |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P860022/S058
6/22/11 |
Boston Equalens/Equalens II | Bausch & Lomb Incorporated
Rochester, NY 14609 |
Alternate supplier of 0.2 micron formulation filter. |
P880047/S016
6/30/11 |
GYNECARE INTERCEED Absorbable Adhesion Barrier | Ethicon, Inc.
Somerville, NJ 08876 |
Alternative cycle parameters for the manufacturing process. |
P890003/S223
6/8/11 |
Prodigy IPG | Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P890003/S224
6/9/11 |
Prodigy IPG | Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P890003/S225
6/10/11 |
CapSure (Drug Eluting), ECG Cable | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P900060/S042
6/30/11 |
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve |
Sorin Group USA, Inc.
Arvada, CO 80004 |
Change of a supplier for lock wire components. |
P900060/S043
6/30/11 |
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve |
Sorin Group USA, Inc.
Arvada, CO 80004 |
Analytical services supplier change. |
P900060/S044
6/30/11 |
Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve |
Sorin Group USA, Inc.
Arvada, CO 80004 |
Addition of a new Optical OGP SmartScope System to an existing component inspection. |
P900061/S103
6/10/11 |
Upsizing Sleeve for HV Lead DF-1, Upsizing Sleeve, Epicardial Patch Leads |
Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P910001/S048
6/8/11 |
ELCA Coronary Artherectomy Catheters | Spectranetics Corporation
Colorado Springs, CO 80921 |
Addition of an alternate supplier for a device component. |
P910007/S030
6/24/11 |
ARCHITECT Total PSA | Abbott Laboratories
Abbott Park, IL 60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays. |
P910073/S097
6/2/11 |
Endotak Reliance EZ, Endotak Reliance RX, Endotak Reliance 4-site EZ and Endotak Reliance 4-site RX Leads |
Boston Scientific Corporation
St. Paul, MN 55112 |
Reduction in sample size. |
P910073/S098
6/17/11 |
ENDOTAK Lead, ENDOTAK RELIANCE Lead, ENDOTAK Endurance Lead Brady Adapter, and Tachy Adapter |
Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P910077/S116
6/17/11 |
ENDOTAK Lead, Tachy Adapter | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P920015/S077
6/10/11 |
Transvene SVC Lead | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P930029/S030
6/10/11 |
RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, RF Conactr |
Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P930039/S053
6/10/11 |
Vitatron Pirouet/S+, Vitatron Crystalline ActFix, CapSure | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P930039/S055
6/29/11 |
CapSureFix and Crystalline Act Fix | Medtronic, Inc.
Mounds View, MN 55112 |
A lead assembly crimping process improvement. |
P950020/S044
6/30/11 |
Flextome® Cutting Balloon® Dilation Device | Boston Scientific Corporation
Maple Grove, MN 55311 |
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component. |
P960006/S031
6/17/11 |
FLEXTEND Lead | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P960009/S116
6/16/11 |
Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator, Kinetra Implantable Neurostimulator, Leads, Stereotactic Frame Lead Kit
Extensions, Adaptors, Accessory Kits used with Deep Brain |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P960009/S117
6/17/11 |
7426 Soletra INS, 7428 Kinetra INS, 37601 Activa PC INS, 37602 Activa SC INS, 37603 Activa SC INS, and 37612 Activa RC INS |
Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an ethylene oxide sterilizer system. |
P960009/S118
6/22/11 |
Activa SC, Soletra, Kinetra | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an alternate qualified supplier for components used in the feedthrough assembly. |
P960040/S244
6/17/11 |
CONFIENT PG, VENTAK PRIZM PG, VITALITY PG, TELIGEN PG | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P960042/S030
6/8/11 |
SLS Spectranetics Laser Sheaths | Spectranetics Corporation
Colorado Springs, CO 80921 |
Addition of an alternate supplier for a device component. |
P970003/S127
6/3/11 |
VNS Therapy System Pulse Generator | Cyberonics
Houston, TX 77058 |
Make changes to software used in an electrical testing system. |
D970003/S129
6/17/11 |
INSIGNIA PG, ALTRUA PG | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P970004/S113
6/16/11 |
Interstim Family of Implantable Neurostimulators
Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Control Magnet |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P970004/S114
6/17/11 |
3023 InterStim INS and 3058 InterStim II INS | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an ethylene oxide sterilizer system. |
P970004/S115
6/22/11 |
InterStim Family | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an alternate qualified supplier for components used in the feedthrough assembly. |
P970012/S085
6/10/11 |
Kappa 400 IPG | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P970027/S014
6/22/11 |
AxSYM Anti-HCV | Abbott Laboratories
Abbott Park, IL 60064 |
Modification to a supplier of the antifoam solution used in AxSYM Anti-HCV. |
P970037/S006
6/24/11 |
AutoDELFIA/DELFIA Xpress hAFP Test System | PerkinElmer, Inc. Waltham, MA 02451 | Change in the TOPO (Trioctylphosphine oxide) raw material type used in the manufacturing of the DELFIA Inducer. |
P970051/S071
6/15/11 |
Nucleus 24 Cochlear Implant System | Cochlear Americas
Centennial, CO 80111 |
Change from a manual assembly to an automated assembly of the case of the sound processor battery pack. |
P970051/S076
6/15/11
|
Nucleus 24 Cochlear Implant System | Cochlear Americas
Centennial, CO 80111 |
Extension of the cure time in the moulding process. |
P970051/S077
6/15/11 |
Nucleus 24 Cochlear Implant System | Cochlear Americas
Centennial, CO 80111 |
Changes to the production of the solid ball assembly electrode. |
P980006/S019
6/10/11 |
Bausch & Lomb PureVision (balafilcon A) Soft Contact Lenses |
Bausch & Lomb, Incorporated
Rochester, NY 14609 |
Upgrade the Cognex software for the automated Wet Vision Automated Inspection System (AIS) to Version 4.4. |
P980007/S021
6/24/11 |
ARCHITECT Free PSA | Abbott Laboratories
Abbott Park, IL 60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays. |
P980016/S300
6/8/11 |
Secura DR/VR t Virtuoso II DR /VR, Maximo II DR/VR t EnTrust,
Virtuoso, Maximo, Intrinsic, Protecta, and Protecta XT Families ICDs |
Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P980016/S301
6/9/11 |
Entrust, Intrinsic, Marquis, Maximo, Maximo II, Maximo II M4, Protecta XT/ Protecta, Protecta XT M4, Protecta M4, Secura, Secura M4, Virtuoso, Virtuoso II ICDs |
Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P980016/S302
6/10/11 |
Protecta DR, Protecta VR, Protecta XT DR and Protecta XT VR ICDs |
Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P980035/S224
6/8/11 |
Adpta/Versa/Sensia, Sigma, Relia, Advisa DR, EnRythm Families of IPGs |
Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P980035/S225
6/9/11 |
Adapta, Advisa, EnRhythm, Relia, Sensia, Versa IPGs | Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P980035/S226
6/10/11 |
Advisa DR IPG | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P980035/S229
6/22/11 |
Advisa IPG | Medtronic, Inc. Mounds View, MN
55112 |
Changes to testing software. |
P980037/S037
6/8/11 |
AngioJet Rheolytic Thrombectomy System | Medrad, Inc.
Minneapolis, MN 55433 |
Modification of a wiping procedure. |
P990034/S022
6/16/11 |
Side Catheter Access Port Kits
Side Catheter Access Port Kits, bulk, Refill Kits Refill Kits, bulk |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P010012/S267
6/17/11 |
EASYTRAK Lead, ACUITY Lead, CONTAK RENEWAL PG, LIVIAN ICD, COGNIS, Left Ventricular Lead Adapter |
Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P010013/S036
6/29/11 |
NovaSure Impedance Controlled Endometrial | Hologic, Inc.
Marlborough, MA 01752 |
Change in manufacturing materials. |
P010015/S122
6/8/11 |
Syncra and Consulta CRT-Ps | Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P010015/S123
6/9/11 |
Consulta/Syncra CRT-PS | Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P010015/S124
6/10/11 |
Syncra and Consulta CRT-P | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P010015/S127
6/22/11 |
Consulta CRT-P, Syncra
CRT-P |
Medtronic, Inc. Mounds View, MN
55112 |
Changes to testing software. |
P010031/S254
6/8/11 |
Consulta, Concerto II, Maximo II and InSync II Protect Families of CRT-Ds; Concerto, InSync II, Marquis DR, InSync III Marquis,
InSync Marquis, InSync Maximo, and InSync Sentry Families of |
Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P010031/S255
6/9/11 |
Concerto, Concerto II, Consulta, Consulta DF4, InSync II Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Maximo II M4, Protecta XT/ Protecta CRT-D, Protecta XT M4/ Protecta M$ CRT-Ds |
Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P010031/S256
6/10/11 |
Protecta and Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P010062/S009
6/22/11 |
Boston Orthokeratology Shapring Lens for Overnight Wear | Bausch & Lomb Incorporated
Rochester, NY 14609 |
Alternate supplier of 0.2 micron formulation filter. |
P020004/S063
6/8/11 |
Gore Excluder AAA Endoprosthesis | W.L. Gore & Associates Inc.
Flagstaff, AR 86003 |
Automation of a bonding process. |
P020009/S074
6/30/11 |
Express 2® Coronary Stent System | Boston Scientific Corporation
Maple Grove, MN 55311 |
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component. |
P030005/S076
6/2/11 |
Contak Renewal Models | Boston Scientific Corporation
St. Paul, MN 55112 |
Various changes in hybrid level test. |
P030005/S077
6/17/11 |
CONTAK RENEWAL TR PG | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P030017/S120
6/16/11 |
Precision Spinal Cord Stimulator System, Implantable Pulse Generator Charge Coil |
Boston Scientific Neuromodulation Valencia, CA
91355 |
Addition of an alternate qualified supplier for components used in assembly of the device. |
P030026/S023
6/14/11
|
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator |
Ortho-Clinical Diagnostic, Inc.
Rochester, NY 14626 |
Manufacturing process change for the manufacture and storage of the antifoam solution used in the VITROS Anti-HBc IgM Conjugate Reagent. |
P030050/S010
6/14/11 |
Sculptra and Sculptra Aesthetic (infectable poly-L- lactic acid) |
Sanofi-Aventis U.S., Inc.
Bridgewater, NJ 08807 |
Change the location of the Design Control Center for Sculptra and Sculptra Aethetic from Sanofi Aventis U.S. LLC, Bridgewater, New Jersey to Anagni Italy. |
P030052/S007
6/1/11 |
UroVysion Bladder Cancer Kit Assay | Abbott Molecular, Inc.
Des Plaines, IL 60018 |
Implementation of process change to the manufacture of the FISH DNA bulk probe solution, including a new fISH DNA extraction process, a new sonication equipment, a new amination/labeling procedure, and a supplemental DNA purification processing step to reduce RNA carry-over. |
P040002/S032
6/30/11 |
Powerlink Stent with IntuiTrak Delivery System | Endologix, Inc.
Irvine, CA 92618 |
Alternate supplier of suture material. |
P040014/S017
6/6/11 |
Therapy, Therapy Bi-Directional and Therapy 4 mm Thermistor Cardiac Ablation Catheters |
St. Jude Medical
Irvine, CA 92614 |
Implement an additional manufacturing rework step. |
P040016/S072
6/30/11 |
VeriFLEX™ Bare-Metal Coronary Stent System | Boston Scientific Corporation
Maple Grove, MN 55311 |
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component. |
P040042/S022
6/6/11 |
Therapy Dual 8, Therapy 8mm Thermistor and Safire TX Ablation Catheters |
St. Jude Medical
Irvine, CA 92614 |
Implement an additional manufacturing rework step. |
P040045/S019
6/10/11 |
VISTAKON® (etafilcon A) and (senofilcon) Brand Contact Lenses |
Vision Care, Inc.
Jacksonville, FL 32256 |
Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer. |
P040045/S020
6/8/11 |
VISTAKON® (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Evaluation of the automation of the repackaging activities conducted by a qualified supplier. |
P040045/S021
6/16/11 |
VISTAKON® (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses. |
P040045/S022
6/15/11 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Addition of a cure tunnel lane. |
P040045/S023
6/22/11 |
VISTAKON (senofilcon A) Brand Contact Lenses | Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256 |
Use an electronic Raw Material Tracking System. |
P050042/S013
6/24/11 |
ARCHITECT ANTI-HCV | Abbott Laboratories Abbott Park, IL
60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays. |
P050046/S011
6/17/11 |
ACUITY Lead | Boston Scientific Corporation
St. Paul, MN 55112 |
Alternate ingredient for the adhesive used in sterile packaging. |
P050051/S013
6/24/11 |
ARCHITECT AUSAB | Abbott Laboratories Abbott Park, IL
60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays. |
P060001/S014
6/27/11 |
Protégé GPS & Protégé RX Carotid Stent System |
Ev3 Endovascular Inc.
Plymouth, MN 55441 |
Alternate etching process for sphere components. |
P060007/S015
6/24/11 |
ARCHITECT HBsAg, ARCHITECT HBsAg Confirmatory | Abbott Laboratories Abbott Park, IL
60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays. |
P060008/S071
6/30/11 |
TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent Systems |
Boston Scientific Corporation
Maple Grove, MN 55311 |
Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component. |
P060010/S009
6/14/11 |
The Spanner Temporary Prostatic Stent | AbbeyMoor Medical, Inc.
Parkers Prairie, MN 56351 |
Minor formulation change in a raw material. |
P060022/S011
6/8/11 |
Akreos Posterior Chamber Intraocular Lens | Bausch & Lomb Inc.
Aliso Viejo, CA 92656 |
Addition of an alternate facility as a source or the Akreos lens button and an alternate supplier of methyl methacrylate. |
P060035/S009
6/24/11 |
ARCHITECT CORE-M | Abbott Laboratories Abbott Park, IL
60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays. |
P080006/S026
6/2/11 |
Attain Ability Family of Leads | Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an additional testing laboratory for sterilization. |
P080006/S027
6/8/11 |
Attain Ability | Medtronic, Inc.
Mounds View, MN 55112 |
Update to the sterile packaging operation process. |
P080006/S028
6/10/11 |
Attain Ability Plus, Attain Ability Straight | Medtronic, Inc. Mounds View, MN
55112 |
Change the cleaning area of the devices. |
P080014/S008
6/23/11 |
Cervista® Papilloma Virus (HPV) High Risk (HR) | Hologic LP
Marlborough, MA 01752 |
Addition of a new supplier of Bovine Serum Albumin (BSA). |
P080015/S004
6/23/11 |
Cervista® Human Papilloma Virus (HPV) 16/18 | Hologic LP
Marlborough, MA 01752 |
Addition of a new supplier of Bovine Serum Albumin (BSA). |
P080023/S009
6/24/11 |
ARCHITECT CORE | Abbott Laboratories Abbott Park, IL
60064 |
Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays. |
P080025/S005
6/16/11 |
Interstim Family of Implantable Neurostimulators,
Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Control Magnet |
Medtronic, Inc.
Minneapolis, MN 55432 |
Implement or change software used for manufacturing of several devices. |
P080025/S006
6/17/11 |
InterStim INS and 3058 InterStim II INS | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an ethylene oxide sterilizer system. |
P080025/S007
6/22/11 |
InterStim Family | Medtronic Neuromodulation
Minneapolis, MN 55432 |
Addition of an alternate qualified supplier for components used in the feedthrough assembly. |
P090013/S023
6/8/11 |
Revo MRI IPG | Medtronic, Inc.
Mounds View, MN 55112 |
Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test. |
P090013/S024
6/9/11 |
Revo MRI IPG | Medtronic, Inc.
Mounds View, MN 55112 |
Addition of an ethylene oxide (EtO) sterilizer system. |
P090013/S026
6/29/11 |
CapSureFix MRI | Medtronic, Inc.
Mounds View, MN 55112 |
A lead assembly crimping process improvement. |
P100023/S001
6/7/11 |
Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation
Maple Grove, MN 55311 |
Changes to your cut-to-length process during catheter assembly. |
P100023/S004
6/29/11 |
Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation
Maple Grove, MN 55311 |
Changes to the proximal Heat Shrinking Removal Inspection Process. |
Summary of PMA Originals & Supplements
Approved
Originals: 4
Supplements: 78
Summary of PMA Originals Under Review
Total Under Review: 93
Total Active: 35
Total On Hold: 58
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 691
Total Active: 501
Total On Hold: 190
Number Greater Than 180 Days: 11
Summary of All PMA Submissions Received
Originals: 3
Supplements: 98
Summary of PMA Supplement PMA Approval/Denial Decision
Times
Number of Approvals: 78
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 116.2
FDA Time: 93.3 Days MFR Time: 22.9 Days
SOURCE