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Medical Devices
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February 2007 PMA Approvals
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. Information about the PDF Reader is available.
PMA Original Approvals
| P050013 2/16/07 |
Histoacryl® and Histoacryl® Blue Topical Skin Adhesive | Kamm and Associates Deerfield , IL 60015 |
Approval for the Histoacryl® and Histoacryl® Blue Topical Skin Adhesive. The device is indicated for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. Histoacryl® and Histoacryl® Blue Topical Skin Adhesive may be used in conjunction with but not in place of dermal sutures. |
PMA Supplemental Approvals
| N16837/S005 2/16/07 Real-Time |
Artegraft™ and Reinforced Artegraft™ | Artegraft, Inc. North Brunswick , NJ 08902 |
Approval for changes to the primary package and to the shrink seal. |
| P860057/S037 2/8/07 Real-Time |
Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis Models 3000 and 3000TFX (aortic), and 6900P and 6900PTFX (mitral) | Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for a reduction in the stitch density of the anchor stitch seamline and final alternating stitch seamline process of the bioprosthetic stent subassembly. |
| P860057/S041 2/13/07 Real-Time |
Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis Models 3000 and 3000TFX | Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for a manufacturing process enhancement for the Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis Models 3000 and 3000TFX polyester band/Elgiloy band sub-assembly joining technique consisting of sewing through all of the band holes. |
| P910077/S066 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P940031/S059 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P950022/S033 2/15/07 135-Day |
Riata ST Family of Leads | St. Jude Medical, CRMD Sylmar , CA 91342 |
Approval to add an automated trimming fixture to trim excess silicone adhesive on the shock electrodes during production of the Riata ST family of leads. |
| P950037/S044 2/15/07 135-Day |
Solox VDD, Selox SR, Selox ST, Selox JT and Setrox S Cardiovascular Permanent Pacemaker Electrode |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changes to the blister package and outer sales box. |
| P950037/S050 2/13/07 Real-Time |
Philos DR-T and Cylos DR-T | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for modifications to the CardioMessenger and CardioMessenger II used with the referenced devices. The devices, as modified, will be marketed under the trade names: CardioMessenger TLine and CardioMessenger II LLT and are indicated for transmitting diagnostic patient data from the device to the physician. |
| P960004/S038 2/28/07 135-Day |
FINELINE II & THINLINE II Atrial Leads | Boston Scientific Corporation St. Paul , MN 55112 |
Process change to the FINELINE II and THINLINE II J-forming manufacturing method to improve retention characteristics of the atrial J-shape. |
| P960040/S135 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P960058/S055 2/26/07 135-Day |
HiResolution Bionic Ear System | Advanced Bionics Corporation Sylmar , CA 91343 |
Approval for a modification to the fixture (T7181) used in the Helium Leak testing of the HiRes90K implant. |
| P970003/S068 2/8/07 180-Day |
VNS Therapy™ System | Cyberonics Houston , TX 77058 |
Approval for use of an additional sterilization method. |
| P970003/S075 2/12/07 180-Day |
VNS Therapy™ System | Cyberonics Houston , TX 77058 |
Approval for the post-approval study. |
| D970003/S081 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P970058/S024 2/9/07 180-Day |
ImageChecker® Computer-aided Detection (CAD) System for Mammography | Hologic, Inc. Bedford , MA 01730 |
Approval for a manufacturing site located at Hologic, Inc., Bedford, Massachusetts. |
| P980016/S090 2/15/07 Real-Time |
Virtuoso Models D154AWG/ D154VWC Implantable Device | Medtronic, Inc. Shoreview , MN 55126 |
Approval for firmware updates to 1) address a “soft” rate limit Power on reset, 2) load a temperature sensitivity update at the time of manufacturing, and 3) load OptiVol enhancements (for use outside of the United States only) at the time of manufacturing. |
| P980022/S018 2/6/07 Real-Time |
MiniLink Transmitter (MMT-7703), MiniLink Charger (MMT-7705), and MiniLink Test Plug (MMT-7706) |
Medtronic MiniMed Northridge , CA 91325 |
Approval for the MiniLink Transmitter (MMT-7703), MiniLink Charger (MMT-7705), and MiniLink Test Plug (MMT-7706). |
| P980023/S022 2/15/07 135-Day |
Kainox RV, Kainox RV-S, Kentrox SL-S Steroid, Kentrox RV-S Steroid, Kentrox SL Steroid, Kentrox RV steroid, and Linox SD ICD Lead |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changes to the blister package and outer sales box. |
| P980037/S019 2/2/07 135-Day |
XMI™ and XMI™-RX Thrombectomy Catheters | Possis Medical, Inc. Minneapolis , MN 55433 |
Approval for a change in sequence for the coating application of the catheter assembly. |
| P980044/S005 2/13/07 135-Day |
SUPARTZ® | Seikagaku Corporation Tokyo , Japan 100-0005 |
Approval for the elimination of a step in the active ingredient sodium hyaluronate manufacturing process and moving that manufacturing process from the current two buildings to a new wing in an existing building. |
| P990020/S024 2/15/07 Real-Time |
AneuRx AAAdvantage Xcelerant Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Approval for minor modifications to the graft cover assembly used in the device. |
| P000009/S018 2/15/07 135-Day |
Kainox A+ ICD Lead | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for changes to the blister package and outer sales box. |
| P000043/S010 2/8/07 180-Day |
TMx-3000™ TherMatrx® Office Thermotherapy™ System | American Medical Systems Minnetonka , MN 55343 |
Approval for an upgrade of the device including a modification of the main console, computer and software. The device, as modified, will be marketed under the trade name TMx-3000™ TherMatrx® Office Thermotherapy™ System and is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men who have a minimum prostatic urethra length f 25 mm and a total prostate volume between 30 and 100 cc. |
| P000053/S007 2/7/07 180-Day |
American Medical Sphincter 800 Urinary Control System | American Medical, Inc. West Minnetonka , MN 55343 |
Approval of the post-approval study protocol. |
| P010003/S009 2/12/07 Special |
BioGlue® Surgical Adhesive | CryoLife, Inc. Kennesaw , GA 30144 |
Approval for additional precautionary statements, and other minor modifications to the Instructions for Use of the cartridge and syringe labels. |
| P010012/S142 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P010031/S058 2/15/07 Real-Time |
Concerto Model C154DWK Implantable Device | Medtronic, Inc. Shoreview , MN 55126 |
Approval for firmware updates to 1) address a “soft” rate limit Power on reset, 2) load a temperature sensitivity update at the time of manufacturing, and 3) load OptiVol enhancements (for use outside of the United States only) at the time of manufacturing. |
| P010062/S005 2/1/07 Real-Time |
Boston® Orthokeratology (oprifocon A) Shaping Lenses for Overnight Wear for Bausch & Lomb Vision Shaping Treatment VST® | Bausch & Lomb Rochester , NY 14609 |
Approval for removing Unival D-49 from the formulation for oprifocon A, and the requested labeling changes. |
| P020009/S033 2/12/07 135-Day |
Express 2 Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to add an automated stent inspection step for the stent component of the device. |
| P020047/S007 2/9/07 Real-Time |
MULTI-LINK VISION® Coronary Stent System and MULTI-LINK MINI Vision® Coronary Stent System | Abbott Vascular Temecula , CA 92591 |
Approval for minor modifications to the W-crest portion of both MULTI-LINK VISION® Stent Systems as well as a non-linear link shift to the Medium design MULTI-LINK VISION® Coronary Stent System. |
| P030005/S039 2/8/07 Real-Time |
All Pulse Generator Models | Guidant Corp. St. Paul . MN 55112 |
Approval for the Guidant Pulse Generator replacement Guide which provides implanting physicians with general advice about removal and replacement of pulse generators reaching end of life. |
| P030012/S002 2/9/07 180-Day |
ImageChecker® CT Lung CAD System | Hologic, Inc. Bedford , MA 01730 |
Approval for a manufacturing site located at Hologic, Inc., Bedford, Massachusetts. |
| P030017/S016 2/1/07 Real-Time |
PRECISION® Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for changing the material of construction for the Passing Elevator, a surgical tool used with the Artisan 2.8 Surgical Lead, from Cycoloy to Pebax. |
| P030017/S017 2/15/07 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for Precision OMG (Observational Mechanical Gateway) Connector-A. |
| P030025/S039 2/12/07 135-Day |
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to add an automated stent inspection step for the stent component of the device. |
| P030030/S005 2/16/07 Special |
Tegress™ Urethral Implant | C.R. Bard, Inc. Covington , GA 30014 |
Approval for changes to the Tegress™ Urethral Implant Instructions for Use and Patient Information brochure to minimize the incidence of adverse events (e.g., erosion and necrosis) and enhance the safety of device use. |
| P030052/S002 2/6/07 Real-Time |
UroVysion™ Bladder Cancer Kit | Abbott Molecular, Inc. Des Plaines , IL 60018 |
Approval for the addition of the ThermoBrite automated slide heating plate supplied by an alternate vendor as an optional alternative of the HYBrite™ automated slide heating plate instrument and to add instructions for use of said ThermoBrite to the current UroVysion™ Bladder Cancer kit package insert. |
| P030054/S034 2/2/07 180-Day |
St. Jude Medical Epic™ + HF Model V-352, Atlas Ò + HF Model V-344, Epic II + HF Model V-356 and Atlas II + HF Model V-366 Cardiac Resynchronization Therapy Defibrillators | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the addition of the AF Suppression Pacing feature. The systems listed above are indicated as follows: The system is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF suppression pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. In patients indicated for an ICD, the system is also intended: 1) to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; 2) to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure. |
| P040003/S002 2/27/07 180-Day |
ExAblate® 2000 System | InSightec- North America Dallas , TX 75207 |
Approval to implement the version 4.2 software and a new patient table (with other related hardware) that allow for operation of the ExAblate® 2000 System with the General Electric 3T Magnetic Resonance Imaging (MRI) System. Version 4.2 software provides for an interleaved mode of operation, elongated focal spots, and a scale-able cooling during. |
| P040016/S018 2/12/07 135-Day |
Liberté MR & OTW Coronary Stent System | Boston Scientific Cardiovascular Maple Grove , MN 55311 |
Approval to add an automated stent inspection step for the stent component of the device. |
| P040033/S002 2/23/07 180-Day |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Inc. Memphis , TN 38116 |
Approval for a manufacturing site located at Smith & Nephew Orthopaedic Ltd. In Warwickshire, United Kingdom, for purchasing, receiving acceptance activities, storage and release and dispatch of product. |
| P040037/S002 2/8/07 180-Day |
GORE VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff , AZ 86003 |
Approval for modifications to the endoprosthesis and delivery catheter design to reduce the overall delivery profile of the device by one french size. |
| P040038/S007 2/5/07 180-Day |
XACT Carotid Stent | Abbott Vascular Devices Santa Clara , CA 95054 |
Approval of the post-approval study. |
| P050007S001 2/2/07 Panel |
StarClose™ Vascular Closure System, Model 1004, Version 2.10 | Abbott Vascular Devices Redwood City , CA 94063 |
Approval for the StarClose™ Vascular Closure System. This device is indicated as follows: The StarClose™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing times to hemostasis and ambulation, in patients who have undergone diagnostic or interventional endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. The StarClose™ Vascular Closure System is indicated for the percutaneous closure of common femoral artery access sites while reducing time to dischargeability in patients who have undergone diagnostic endovascular catheterization procedures utilizing a 5F or 6F procedural sheath. |
| P050023/S003 2/13/07 Real-Time |
Kronos LV-T CRT-D and Lumax Family of ICDs | Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for modifications to the CardioMessenger and CardioMessenger II used with the referenced devices. The devices, as modified, will be marketed under the trade names: CardioMessenger TLine and CardioMessenger II LLT and are indicated for transmitting diagnostic patient data from the device to the physician. |
30-Day Notices (135 Day Supplement was not required)
| P810006/S027 2/9/07 |
CollaStat® Absorbable Collagen Agents | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Alternate alkali treatment production area. |
| P810032/S053 2/9/07 |
Multi-Piece PMMA Posterior Chamber Intraocular Lenses | Alcon Research, Ltd. Fort Worth , TX 76134 |
Change in the J.D. Edwards software module to allow users to identify the location of a lot of raw material which has expired. |
| P820060/S021 2/1/07 |
Abbott AFP-EIA Diagnostic Kit | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P840062/S012 2/9/07 |
CollaCote® Absorbable Collagen Wound Dressing | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Alternate alkali treatment production area. |
| P850010/S024 2/9/07 |
Helistat® Absorbable Collagen Agents | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Alternate alkali treatment production area. |
| P900033/S015 2/9/07 |
INTEGRA® Dermal Regeneration Template | Integra LifeSciences Corporation Plainsboro , NJ 08536 |
Alternate alkali treatment production area. |
| P910007/S016 2/1/07 |
Abbott IMx SA | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P950020/S024 2/2/07 |
Cutting Balloon™ Ultra 2 Monorail (MR) PTCA Catheter (Cutting Balloon) | Boston Scientific Corporation San Diego , CA 92123 |
Change in the sterilization method as well as a change in dimensions of the outer shipping box for the Cutting Balloon™. |
| P950020/S025 2/23/07 |
Cutting Balloon™ Ultra 2 Monorail | Boston Scientific Corporation San Diego , CA 92123 |
Addition of in-process and post-sterile destructive pull tests. |
| P960040/S140 2/15/07 |
Vitality and Vitality AVT Family of Cardiac Resynchronization Therapy Defibrillators (CRT-D) | Guidant Corp. St. Paul , MN 55112 |
Modifications to several device functional tests. |
| P960040/S142 2/16/07 |
VITALITY HE Cardiac Resynchronization Therapy Defibrillator (CRT-D) | Guidant Corp. St. Paul , MN 55112 |
Changes to the solder ball inspection testing process. |
| D970003/S083 2/21/07 |
PULSAR / PULSAR MAX / INSIGNIA / NEXUS Pulse Generators | Guidant Corp. St. Paul , MN 55112 |
Addition of an inspection step and adjusted equipment settings. |
| D970003/S084 2/28/07 |
INSIGNIA / MNEXUS Family of Devices | Guidant Corp. St. Paul , MN 55112 |
Changes to the curing process of the underfill epoxy on hybrid components of INSIGNIA/NEXUS family of devices for throughput and yield improvement. |
| D970012/S035 2/23/07 |
AMS 700 Inflatable Penile Prosthesis | American Medical Systems Minnetonka , MN 5534 |
Change to make an in-process test optional for the device. |
| P970020/S048 2/16/07 |
Multi-Link Vision® Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Modification in the dose range and conveyor speed for e-beam sterilization for the Multi-Link® and Multi-Link Vision® Coronary Stent Systems. |
| P970027/S005 2/5/07 |
Abbott AxSYM Antibody to HCV | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P980007/S008 2/1/07 |
Abbott IMx Free PSA | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P990020/S025 2/23/07 |
Medtronic Vascular AneuRx Stent Graft with Xcelerant Delivery System | Medtronic Vascular Santa Rosa , CA 95403 |
Change to the manufacturing process to include an alternative location for a catheter coating operation. |
| P000012/S012 2/28/07 |
COBAS AMPLICOR Hepatitis C Virus (HCV) Test, version 2.0 | Roche Molecular System, Inc. Pleasanton , CA 94566 |
Manufacturing scale-up of a raw material vendor, conversion of a manufacturing room to a more restrictive environment, and installation of a new labeling system. |
| P010012/S147 2/16/07 |
CONTAK RENEWAL 3 Pulse Generator | Guidant Corp. St. Paul , MN 55112 |
Changes to the solder ball inspection testing process. |
| P010015/S026 2/23/07 |
Attain® Over The Wire Left Ventricular Model 4193 Lead | Medtronic, Inc. Shoreview , MN 55126 |
Minor changes to the connector assembly. |
| P020040/S002 2/2/07 |
NIRFLEX™ Pre-Mounted Coronary Stent System | Medinol, LTD. Tel-Aviv , Israel 61581 |
Change to the ETO load configuration for sterilization of the device. |
| P020040/S003 2/2/07 |
NIRFLEX™ Pre-Mounted Coronary Stent System | Medinol, LTD. Tel-Aviv , Israel 61581 |
Change in the welding process in the manufacture of the device. |
| P020040/S004 2/15/07 |
NIRFLEX™ Premounted Coronary Stent System | Medinol Ltd. Boston , MA 02109 |
Change to the PCD configuration used during the EtO sterilization process and removal timing for the incubation of the BIs used during the EtO sterilization process. |
| P020040/S005 2/15/07 |
NIRFLEX™ Premounted Coronary Stent System | Medinol Ltd. Boston , MA 02109 |
Use of an automated stent-Weighing machine during the manufacture of the NIRFLEX™ Stent. |
| P020047/S008 2/16/07 |
Multi-Link® Coronary Stent System | Abbott Vascular, Inc. Temecula , CA 92591 |
Modification in the dose range and conveyor speed for e-beam sterilization for the Multi-Link® and Multi-Link Vision® Coronary Stent Systems. |
| P030005/S041 2/16/07 |
CONTAK RENEWAL TR Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Guidant Corp. St. Paul , MN 55112 |
Changes to the solder ball inspection testing process. |
| P050012/S007 2/26/07 |
DexComSTS System | DexCom, Inc. San Diego , CA 92121 |
Expansion of subcomponent and component manufacturing processes of the STS System to a second facility. |
| P050049/S001 2/5/07 |
Abbott AxSYM HBsAg Assay | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P060003/S003 2/5/07 |
Abbott AxSYM AUSAB | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P060009/S001 2/5/07 |
Abbott AxSYM CORE-M 2.0 and AxSYM CORE-M 2.0 Controls | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
| P060012/S001 2/5/07 |
Abbott AxSYM CORE 2.0 and AxSYM CORE 2.0 Controls | Abbott Laboratories Abbott Park , IL 60064 |
Consolidation of secondary packaging operations from building K2 located in the K-Complex to building AP32 located in Abbott Park. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 44
Summary of PMA Originals Under Review
Total Under Review: 81
Total Active: 37
Total On Hold: 44
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 418
Total Active: 208
Total On Hold: 210
Number Greater Than 180 Days: 13
Summary of All PMA Submissions Received
Originals: 1
Supplements: 78
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 44
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 131.3
FDA Time: 105.7 Days MFR Time: 25.6 Days
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