Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P060027 5/15/08 |
Ovatio CRT-D System | ELA Medical, Inc. Plymouth, MN 55441 |
Approval for the Ovatio CRT-D System. The Ovatio CRT-D is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias. The device is also indicated for the reduction of heart failure symptoms in medically optimized NYHA Functional Class III and IV patients with left ventricular ejection fraction of 35% or less, and a QRS duration of 150 ms or longer. Situs OTW LV lead is designed to pace the left ventricle through a coronary vein. It is intended to be used in conjunction with ELA Medical cardiac synchronization therapy pulse generators. |
| P070008 5/12/08 |
Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead | Biotronik, Inc. Lake Oswego, OR 97035 |
Approval for the Stratos LV CRT-P and Stratos LV-T CRT-P with 702.U Programmer Software for the ICS 3000 and Corox OTW BP Lead and Corox OTW-S BP Lead. The Stratos LV CRT-P and the Stratos LV-T CRT-P are indicated for patients who have moderate to severe heart failure (NYHA Class II1/IV), including left ventricular dysfunction (EF< 35%) and QRS > 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy. The Corox OTW BP and Corox OTW-S BP left ventricular pacing leads are bipolar steroid-eluting leads, intended for permanent implantation in the left ventricle via the coronary veins to provide pacing and/or sensing when used in conjunction with a compatible IS-1 pulse generator. |
| P070016 5/21/08 |
Zenith® TX2® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System | Cook, Inc. Bloomington, IN 47404 |
Approval for the Zenith® TX2 ® Thoracic TAA Endovascular Graft with the H&LB One-Shot™ Introduction System. This device is indicated for the endovascular treat ment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair, including: 1) Adequate iliac/femoral access compatible with the required introduction systems; and 2) Non-aneurysmal aortic segments (fixation sites) proximal and distal to the aneurysm or ulcer: a) with a length of at least 25 mm; and b) with a diameter measured outer wall to outer wall of no greater than 38 mm and no less than 24 mm. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P820003/S082 5/9/08 180-Day |
Various Families of Pacemaker | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P820060/S023 5/21/08 180-Day |
Abbott Architect® AFP | Abbott Laboratories Abbott Park, IL 60064 |
Approval for: 1) creation of AFP WHO primary calibrators and controls; 2) assay software changes: a) volume of sample in the pipetting protocol; b) dilution of specimen in the automated dilution protocols; and c) dilution parameters; 3) manual diluent change; and 4) New control concentrations. |
| P850048/S021 5/9/08 Panel |
Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems | Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for the Access® Hybritech® PSA reagents on the Access® Immunoassay Systems. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) in human serum using the Access Immunoassay Systems. The device is indicated for the measurement of serum PSA in conjunction with digital rectal examination (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Prostate biopsy is required for the diagnosis of cancer. The device is further indicated for the serial measurement of PSA to aid in the prognosis and management of patients with prostate cancer. |
| P850051/S066 5/9/08 180-Day |
Various Families of Pacemaker | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P860057/S045 5/23/08 Real-Time |
Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis, Model 2700 Carpentier-Edwards® PERIMOUNT® Theon Pericardial Aortic Bioprosthesis, Model 2700TFX Carpentier-Edwards® PERIMOUNT® RSR Pericardial Aortic Bioprosthesis, Model 2800 Carpentier-Edwards® PERIMOUNT® Theon RSR Pericardial Aortic Bioprosthesis, 2800TFX Carpentier-Edwards® PERIMOUNT Magna® Pericardial Aortic Bioprosthesis, Model 3000 Carpentier-Edwards® PERIMOUNT Magna® Pericardial Aortic Bioprosthesis, Model 3000TFX Carpentier-Edwards® PERIMOUNT Pericardial Bioprosthesis Mitral Model 6900 Carpentier-Edwards® PERIMOUNT Plus® Mitral Pericardial Bioprosthesis, Model 6900P Carpentier-Edwards® PERIMOUNT® Theon Mitral Pericardial Bioprosthesis, Model 6900PTFX |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years. |
| P870056/S028 5/23/08 Real-Time |
Carpentier-Edwards® PERIMOUNT® Porcine Bioprosthesis, Model 2625 and Carpentier-Edwards® PERIMOUNT® Porcin Mitral Bioprosthesis, Model 6625 | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years. |
| P870077/S027 5/23/08 Real-Time |
Carpentier-Edwards® PERIMOUNT® Duraflex Low Pressure Mitral Bioprosthesis, Model 6625LP and Carpentier-Edwards® PERIMOUNT® Duraflex Low Pressure Mitral Bioprosthesis, Model 6625ESR-LP | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years. |
| P880006/S054 5/16/08 180-Day |
Regency Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P880086/S155 5/16/08 180-Day |
AddVent, Affinity, Identity, Verity, Integrity, Victory, and Zephyr Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P890003/S119 5/13/08 Real-Time |
Medtronic nEw3 Platform for the Adapta/Versa/ Sensia Implantable Pacemakers (Model ADDR01, ADDR03, ADDR06, ADDRS1, ADDRL1, ADD01, ADVDD01, ADSR01, ADSR03, ADSR06, VEDR01, SEDR01, SEDRL1, SED01, SESR01, and SES01), Model SW003 Application Software, and Model 2490H Medtronic Carelink® Monitor and Model 2491 DDMA |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic Adapta/Versa/ Sensia Implantable Pacemakers (A/V/S pacemakers), Model SW003 Application Software, and Model 2490H Medtronic Carelink® Monitor and Model 2491 DDMA software. |
| P890003/S129 5/9/08 180-Day |
Various Families of Pacemaker, Carelink Programmer Model | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P900061/S074 5/9/08 180-Day |
Micro Jewel II ICD | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P910023/S159 5/16/08 180-Day |
Cadence ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P910023/S170 5/2/08 Real-Time |
Cadence family of ICDs | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for modifications to the Hercules 2J analog IO chip used in the Current IDC and Promote CRT-D devices. |
| P910071/S011 5/20/08 180-Day |
ADATO-SIL-OL 5000 Silicone Oil | Bausch and Lomb, Inc. San Dimas, CA 91773 |
Approval for a manufacturing site located at Pharmpur Gmbh, Königsbrunn, Germany 86343 |
| P920046/S005 5/15/08 180-Day |
Filshie Clip System | Orchid Design Orthopedic Solutions Shelton, CT 06484 |
Approval for a manufacturing site located at Wesley Coe Ltd., England, United Kingdom. |
| P930022/S006 5/9/08 180-Day |
Legend Plus Families of Pacemaker | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P940035/S004 5/20/08 180-Day |
NMP22® BladderChek® Test Kit | Matritech, Inc. Newton, MA 02460 |
Approval for a manufacturing site located at Binax, Inc., Scarborough, Maine. |
| P950022/S045 5/16/08 180-Day |
Riata, Riata ST, and Durata leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P950027/S009 5/1/08 180-Day |
Hyalgan | Fidia Farmaceutici Via Ponte Della Fabbrica, Italy |
Approval for the modification of the manufacturing process for Hyalgan for producing hyaluronate by a bacterial fermentation and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen. |
| P950027/S011 5/23/08 180-Day |
Hyalgan | Fidia Farmaceutici Via Ponte Della Fabbrica, Italy |
Approval for updating the section of adverse events with a qualitative description of the types and is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy, and to simple analgesics, e.g., acetaminophen. |
| P960013/S035 5/16/08 180-Day |
Tendril, Tendril ST, and OptiSense Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P960028/S027 5/30/08 135-Day |
ReZoom Multifocal Intraocular Lenses | Advanced Medical Optics Santa Ana, CA 92705 |
Approval for a change in the tumbling/polishing process. |
| P960030/S019 5/16/08 180-Day |
Passive Plus, IsoFlex S/P, and IsoFlex Optim Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P960040/S155 5/8/08 180-Day |
TELIGEN Implantable Cardioverter Defibrillator Models E102 and E110, the Application Software Model 2868, Rev. 1.01 and Model 6628 Torque Wrench |
Guidant Corp. A Boston Scientific Company St. Paul, MN 55112 |
Approval for the TELIGEN Implantable Cardioverter Defibrillator Models E102 and E110, the COGNIS Cardiac Resynchronization Therapy Defibrillator (CRT-D) Models N118 and N119, Application Software Model 2868, Rev. 1.01 and the Model 6628 Torque Wrench. The device, as modified, will be marketed under the trade name TELIGEN Implantable Cardioverter Defibrillator Models E102 and E110, the COGNIS Cardiac Resynchronization Therapy Defibrillator (CRT-D) Models N118 and N119, Application Software Model 2868, Rev. 1.01 and the Model 6628 Torque Wrench. The COGNIS CRT-D devices are indicated for patients with moderate-to-severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal failure drug therapy, and have left ventricular (LV) dysfunction (ejection fraction <35%) and QRS duration >120 ms. The TELIGEN devices are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
| P960040/S167 5/8/08 Real-Time |
TELIGEN Family of ICDs | Guidant Corp. St. Paul, MN 55112 |
Approval for updates to the Programmer SW Model 2868 v1.02 and Pulse Generator firmware v1.04.0, Patch v1.00 for the TELIGEN and COGNIS families of devices. |
| P970003/S083 5/1/08 180-Day |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Approval of the post-approval study. |
| P970004/S054 5/30/08 Real-Time |
Medtronic InterStim® Therapy for Urinary Control | Medtronic Neuromodulation Minneapolis, MN 5432 |
Approval for labeling changes to the Programming Guide for Models 8840 N’Vision Clinician Programmer and 8870 N’Vision Application Card, to better describe how to determine the battery status of the Model 3058 InterStim implantable neurostimulator and for additional minor labeling changes. |
| P970012/S030 5/9/08 180-Day |
Kappa 400 Families of Pacemaker | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P970013/S021 5/16/08 180-Day |
Microny Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P970021/S019 5/23/08 Real-Time |
Gynecare ThermaChoice III Uterine Balloon Therapy System | Ethicon, Inc. Somerville, NJ 08876 |
Approval for a modification in the Ethylene Oxide Sterilization process to accommodate a minimum load capacity of one pallet. |
| P980006/S012 5/30/08 Real-Time |
PureVision 2 (balafilcon A) Visibility tinted Contact Lenses, PureVision 2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens, and PureVision 2 Toric (balafilcon A) Visibility Tinted Contact Lens | Bausch & Lomb Rochester, NY 14609 |
Approval for decreasing the center thickness of the PureVision lens and adding 0.3 wt% hydroxypropyl methylcellulose to the packing solution. The device, as modified, will be marketed under the trade name PureVision 2 Visibility Tinted Contact Lenses and is indicated for the following approved indications for use: VISION CORRECTION The BAUSCH & LOMB® PureVision 2 (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +8.00D to –20.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or extended wear up to 7 days. The BAUSCH & LOMB® PureVision 2 Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 2.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -18.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or extended wear up to 7 days with add powers ranging from +0.75D to +5.00D. The BAUSCH & LOMB® PureVision 2 Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. The lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +6.00D to -9.00D when prescribed for up to 30 days of extended wear and from +20.00D to –20.00D for daily wear or extended wear up to 7 days. THERAPEUTIC USE The BAUSCH & LOMB® PureVision 2 (balafilcon A) Visibility Tinted Contact Lens is also indicated for therapeutic use. Use as a bandage contact lens for corneal protection and corneal pain relief during treatment of ocular pathologies as well as post-surgical conditions. Applications of the PureVision 2 Contact Lens include but are not limited to conditions such as the following: 1) For corneal protection in conditions such as entropion, trichiasis, tarsal scars, recurrent corneal erosion and post surgical ptosis for corneal protection; 2) For corneal pain relief in conditions such as bullous keratopathy, epithelial erosion and abrasion, filamentary keratitis, post-keratoplasty; 3) For use as a bandage during the healing process of conditions such as chronic epithelial defects, corneal ulcer, neurotrophic keratitis, neuroparalytic keratitis, chemical burns, and post surgical epithelial defects. 4) For post-surgical conditions that include bandage use such as LASIK, PRK, PK, PTK, lamellar grafts, corneal flaps, and additional corneal surgical conditions. PureVision 2 Contact Lenses for therapeutic use can also provide optical correction during healing if required. |
| P980016/S111 5/9/08 180-Day |
Entrust ICD | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P980016/S120 5/16/08 135-Day |
Marquis DR/VR, Maximo DR/VR, Intrinsic 30/Intrinsic, and EnTrust Family of Implantable Cardioverter Defibrillators (ICDs) | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the vendor’s hybrid tests. |
| P980035/S073 5/13/08 Real-Time |
Medtronic nEw3 platform for the Adapta/Versa/ Sensia Implantable Pacemakers (Model ADDR01, ADDR03, ADDR06, ADDRS1, ADDRL1, ADD01, ADVDD01, ADSR01, ADSR03, ADSR06, VEDR01, SEDR01, SEDRL1, SED01, SESR01, and SES01), Model SW003 Application Software, and Model 2490H Medtronic Carelink® Monitor and Model 2491 DDMA |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the Medtronic Adapta/Versa/ Sensia Implantable Pacemakers (A/V/S pacemakers), Model SW003 Application Software, and Model 2490H Medtronic Carelink® Monitor and Model 2491 DDMA software. |
| P980035/S079 5/9/08 180-Day |
Kappa 700/600 Sigma and Enrhythm IPG’s | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P980035/S085 5/16/08 135-Day |
EnRhythm Family of Implantable Pulse Generators (IPGs) | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the vendor’s hybrid tests. |
| P980040/S021 5/30/08 135-Day |
Sensar Acrylic Intraocular Lenses | Advanced Medical Optics Santa Ana, CA 92705 |
Approval for a change in the tumbling/polishing process. |
| P980040/S023 5/27/08 180-Day |
TECNIS™ One-Piece Intraocular Lens, Model ZCB00 | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Approval for revisions to the labeling for the TECNIS™ One-Piece Intraocular Lens, Model ZCB00 as follows: 1) modifications to the device description section to include an additional description of wavefront-designed aspheric optic, squared posterior optic edge, frosted optic edge, an optical image quality graph for the aspheric optic; 2) modifications to the adverse events sand the clinical trial sections to reflect data from the one-year clinical study results; and 3) other administrative changes such as the rewording of the last sentence on page 1, adding trademarks to the detailed device description section and revision the numbering of the figures. |
| P980050/S030 5/9/08 180-Day |
Jewel AF, Gem III Family of ICD’s | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P990001/S033 5/9/08 180-Day |
Vitatron Pacemaker | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P990066/S030 5/27/08 Real-Time |
GE Senographe DS and Essential full Field Digital Mammography System | GE Healthcare Waukesha, WI 53188 |
Approval for the modification of Automatic Optimization of Parameters (AOP) software to increase contrast to noise ratio for thicker denser breasts. |
| P990080/S030 5/30/08 135-Day |
Tecnis Acrylic Intraocular Lenses | Advanced Medical Optics Santa Ana, CA 92705 |
Approval for a change in the tumbling/polishing process. |
| P000006/S009 5/23/08 Real-Time |
Coloplast Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for a change of accelerated aging temperature from 65 degrees C to 60 degrees C in a stability protocol for the device. |
| P000007/S015 5/23/08 Real-Time |
Edwards Prima Plus® Stentless Bioprosthesis, Model 2500P | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years. |
| P010012/S160 5/16/08 180-Day |
ACUITY™ Spiral Lead Model 4591, 4592, and 4593 | Boston Scientific Corporation CRM St. Paul, MN 55112 |
Approval for the ACUITY™ Spiral Lead Model 4591, 4592, and 4593. The device is indicated for chronic, left-ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible pulse generator. |
| P010012/S165 5/8/08 180-Day |
COGNIS Cardiac Resynchronization Therapy Defibrillator (CRT-D) Models N118 and N119, the Application Software Model 2868, Rev. 1.01 and Model 6628 Torque Wrench |
Guidant Corp. St. Paul, MN 55112 |
Approval for the TELIGEN Implantable Cardioverter Defibrillator Models E102 and E110, the COGNIS Cardiac Resynchronization Therapy Defibrillator (CRT-D) Models N118 and N119, Application Software Model 2868, Rev. 1.01 and the Model 6628 Torque Wrench. The device, as modified, will be marketed under the trade name TELIGEN Implantable Cardioverter Defibrillator Models E102 and E110, the COGNIS Cardiac Resynchronization Therapy Defibrillator (CRT-D) Models N118 and N119, Application Software Model 2868, Rev. 1.01 and the Model 6628 Torque Wrench. The COGNIS CRT-D devices are indicated for patients with moderate-to-severe heart failure (NYHA III/IV) who remain symptomatic despite stable, optimal failure drug therapy, and have left ventricular (LV) dysfunction (ejection fraction <35%) and QRS duration >120 ms. The TELIGEN devices are intended to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. |
| P010012/S179 5/8/08 Real-Time |
COGNIS Family of CRT-Ds | Guidant Corp. St. Paul, MN 55112 |
Approval for updates to the Programmer SW Model 2868 v1.02 and Pulse Generator firmware v1.04.0, Patch v1.00 for the TELIGEN and COGNIS families of devices. |
| P010015/S034 5/9/08 180-Day |
Insync III CRT-IPG | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P010025/S012 5/23/08 Real-Time |
Selenia Full Field Digital Mammography System | Hologic, Inc. Danbury, CT 06810 |
Approval for a change to alter the composition of the selenium layer. |
| P010031/S081 5/9/08 180-Day |
Various Families of CRT/ICD’s | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for Operating System Migration from OS/2 to XPe. |
| P010031/S090 5/16/08 135-Day |
InSync II Marquis, InSync III Marquis, InSync II Protect, InSync Maximo and InSync Sentry Family of Implantable Cardioverter Defibrillators (ICDs) | Medtronic Cardiac Rhythm Disease Management Mounds View, MN 55112 |
Approval for modifications to the vendor’s hybrid tests. |
| P010041/S015 5/23/08 Real-Time |
Carpentier-Edwards® S.A.V. Bioprosthesis, Model 2650 | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval to extend the use of the Sensitech TagAlert™ temperature alarm indicator on the device packaging from transit only to both transit and storage up to four (4) years. |
| P020018/S023 5/9/08 180-Day |
Zenith® AAA Endovascular Graft with H&L-B One-Shot™ Introduction System | Cook Medical, Inc. Bloomington, IN 47402 |
Approval for a manufacturing site located at William Cook Europe, Bjaeverskov, Denmark. |
| P020026/S044 5/29/08 135-Day |
Cypher® Sirolimus-Eluting Coronary Stent System | Cordis Corporation Miami Lakes, FL 33014 |
Approval for a site transfer of the bacterial endotoxins test and bioburden microbiological tests. |
| P020040/S007 5/23/08 135-Day |
Nirflex™ Pre-Mounted Coronary Stent System |
Medinol, Inc. Boston, MA 02109 |
Approval for changing the sterilization load configuration and temperature in the aeration chamber for Nirflex™ stents. |
| P030027/S004 5/8/08 135-Day |
Ceramic TRANSCEND® Articulation System | Wright Medical Technology, Inc. Arlington, TN 38002 |
Approval for the addition of an automated process to specific polishing stations. |
| P030035/S036 5/16/08 180-Day |
Frontier/Frontier II CRT-P’s and Aescula Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P030054/S072 5/16/08 180-Day |
Epic HF CRT-D and QuickSite & QuickFlex Leads | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for a manufacturing site located at Steri-Tech, Inc., Salinas, Puerto Rico for Ethylene Oxide sterilization of the pacemakers, ICDs and leads. |
| P030054/S084 5/2/08 Real-Time |
Epic HF/Atlas+ HF Family of CRT-D | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for modifications to the Hercules 2J analog IO chip used in the Current IDC and Promote CRT-D devices. |
| P040021/S006 5/6/08 180-Day |
SJM Biocor Valve & SJM Biocor Supra Valve | St. Jude Medical St. Paul, MN 55117 |
Approval of the post-approval study. |
| P040024/S022 5/30/08 Special |
Restylane® Injectable Gel | Medicis Aesthetics Holdings, Inc. Scottsdale, AZ 85258 |
Approval for the introduction of a QC sample to the test method for protein content in HA raw material. |
| P040027/S010 5/29/08 135-Day |
Gore VIATORR® TIPS Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for: 1) a change in the type of cooling gas; 2) a change in the application of the coolant; and 3) the addition of a temperature controller. |
| P040037/S009 5/29/08 135-Day |
Gore VIABAHN® Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Approval for: 1) a change in the type of cooling gas; 2) a change in the application of the coolant; and 3) the addition of a temperature controller. |
| P040044/S005 5/16/08 135-Day |
Mynx™ Vascular Closure Device | AccessClosure, Inc. Mountain View, CA 94043 |
Approval for the following changes to the manufacturing processes: 1) replacing the heated die necker machine with a hot air necker machine; and 2) replacing the glass mold baloon blower machine with a metal mold balloon blower machine. |
| P050012/S014 6/15/08 Real-Time |
DexCom Seven System | DexCom, Inc. San Diego, CA 92121 |
Approval for a design modification to allow users of the DexCom Seven System DM2 Data Manager Software to obtain Receiver Firmware updates electronically and remotely using their personal computer. |
| P050020/S002 5/15/08 180-Day |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Laboratories Alameda, CA 94502 |
Approval for: 1) the addition of a carbon coating to the back of the sensor tail to improve adhesion of the membrane in order to eliminate microscopic membrane fragmentation; 2) a change in the orientation of the position of the sensor during the manufacturing process to facilitate inspection; 3) a labeling change, resulting from the backside carbon coating, to eliminate a Caution regarding membrane fragments remaining in the skin; 4) and a change in a sub-supplier manufacturing site, DuPont, Hopewell, Virginia. |
| P050020/S003 5/21/08 Special |
FreeStyle Navigator Continuous Glucose Monitoring System | Abbott Diabetes Care, Inc. Alameda, CA 94502 |
Approval for two labeling modifications: 1) to modify a warning regarding use of the system in an environment where anesthetic gas is used to instead warn against use in environments that contain any combustible gas; and 2) to add language to the instructions for muting alarms to clarify when it is not recommended to do so and also to clarify when the system will go into Abandon Alarm Mode when the alarms are muted. |
| P050037/S004 5/1/08 135-Day |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Approval for new upgraded external interface software for a steam sterilizer. |
| P050044/S005 5/30/08 Special |
Vitagel® Surgical Hemostat | Orthovita, Inc. Malvern, PA 19355 |
Approval to change the vendor of the 1 liter and 5 liter media bags used to store intermediae solutions during Vitagel Aseptic processing. |
| P050047/S003 5/2/08 Real-Time |
Juvéderm Hyaluronate Gel Implants | Allergan Santa Barbara, CA 93111 |
Approval for the addition of a needle tightening tool with associated revisions to the labeling and modifications to the packaging. |
| P050052/S005 5/1/08 135-Day |
Radiesse® Injectable Implant | BioForm Medical, Inc. Franksville, WI 53126 |
Approval for new upgraded external interface software for a steam sterilizer. |
| P050053/S008 5/13/08 180-Day |
INFUSE® Bone Graft | Medtronic Sofamor Danek, Inc. Memphis, TN 38132 |
Approval for labeling modifications to address warnings about improper preparation of InFuse® Bone Graft and overfilling of bone defects. |
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 |
| N17511/S015 5/14/08 |
Hyskon® Hysteroscopy Fluid | Orchid Design Orthopedic Solutions Shelton, CT 06484 |
Change to the equipment used for capping vials. |
| P810002/S064 5/16/08 |
SJM Mechanical Heart Valve | St. Jude Medical Cardiovascular Division St. Paul, MN 55117 |
Change in supplier that forms the spring used on certain SJM Mechanical Heart Valve Models. |
| P840001/S112 5/22/08 |
Itrel 3, Synergy, Restore Prime, and Prime Advanced Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Modifications to the sterilization process. |
| P840039/S056 5/2/08 |
Polymethylmeth-acrylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the limulus amebocyte lysate (LAL) testing method and a change in the site for the LAL final product testing to Bausch & Lomb, Inc.’s Clearwater, Florida facility. |
| P840064/S035 5/5/08 |
VISCOAT® and DUOVISC® | Alcon Research Ltd. Fort Worth, TX 76134 |
Use of an alternate analytical method for the identification of rubber formulations used in the syringe tip cap and stoppers. |
| P880090/S023 5/2/08 |
Polymethylmeth-acrylate Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the limulus amebocyte lysate (LAL) testing method and a change in the site for the LAL final product testing to Bausch & Lomb, Inc.’s Clearwater, Florida facility. |
| P880091/S026 5/14/08 |
STAAR Surgical Silicone UV-Absorbing Posterior Chamber Intraocular Lens | STAAR Surgical Company Monrovia, CA 91016 |
Change to a new sample holding fixture for the in-process haptic pull test performed on the 3-piece silicone lenses. |
| P890003/S139 5/14/08 |
Various Families of Pacemakers | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P890047/S023 5/5/08 |
PROVISC® | Alcon Research Ltd. Fort Worth, TX 76134 |
Use of an alternate analytical method for the identification of rubber formulations used in the syringe tip cap and stoppers. |
| P900007/S004 5/8/08 |
Cook® Chorionic Villus Sampling Set | Cook Urological, Inc. Bloomington, IN 47404 |
Change in the sterilization agent used in processing the Cook® Chorionic Villus Sampling Set. |
| P900056/S091 5/30/08 |
Rotablator™ Rotational Angioplasty System RotaLink™ Exchangeable Catheter | Boston Scientific Corporation Maple Grove, MN 55311 |
Changes to the manufacturing tolerance specifications of the weld locations. |
| P900060/S040 5/27/08 |
Carbomedics Prosthetic Heart Valve | CarboMedics, Inc. Austin, TX 78752 |
Use of an additional steam sterilization chamber. |
| P900061/S075 5/14/08 |
Various Families of ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P910023/S174 5/15/08 |
CADENCE ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change to the manufacturing process for the high-voltage hybrid assembly. |
| P910061/S016 5/2/08 |
Silicone Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the limulus amebocyte lysate (LAL) testing method and a change in the site for the LAL final product testing to Bausch & Lomb, Inc.’s Clearwater, Florida facility. |
| P910077/S086 5/9/08 |
Model 3120 ZOOM Latitude Programming System | Guidant Corporation BSC CRM Corporation St. Paul, MN 55112 |
Additional supplier for a component (touch screen) used in the Model 3120 ZOOM Latitude Programming System. |
| P920015/S043 5/1/08 |
Sprint, Sprint Quattro, Spring Quattro Secure and Sprint Fidelis Leads |
Medtronic, Inc. Moundsview, MN 55112 |
Change to the cure process at a component supplier. |
| P920015/S044 5/14/08 |
Various Families of Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P920023/S024 5/30/08 |
Urolume Urethral Stent | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| P930038/S055 5/29/08 |
Angio-Seal™ Vascular Closure Device | St. Jude Medical Maple Grove, MN 55311 |
Alternate abattoir to supply bovine hides for collagen used in the manufacture of the device. |
| P950020/S027 5/27/08 |
Flextome™ Cutting Balloon™ Monorail (MR) and Over-the-Wire (OTW) | Boston Scientific Corporation San Diego, CA 92123 |
Change in supplier for the balloon tubing extrusion process. |
| P950024/S010 5/14/08 |
CapSure Epi Epicardial Steroid Eluting Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P950032/S047 5/19/08 |
Apligraf® Skin Construct | Organogenesis Inc. Canton, MA 02021 |
Additional supplier of a raw material used to manufacture the Apligraf® bi-layered skin construct. |
| P960009/S050 5/22/08 |
Kinetra and Soletra Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Modifications to the sterilization process. |
| P960013/S039 5/16/08 |
Tendril Model 1882TC Lead | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Alternate manufacturing tool. |
| P960040/S165 5/19/08 |
PRIZM II and VITALITY Family of Implantable Cardioverter Defibrillators (ICDs) | Guidant Corporation St. Paul, MN 55112 |
Add a second supplier for a component in the hybrid circuit. |
| P960040/S166 5/21/08 |
VITALITY HE Family of Tachy Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Processing of additional product on existing bonder machines. |
| D970003/S098 5/21/08 |
INSIGNIA and ALTRUA Family of Brady Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Processing of additional product on existing bonder machines. |
| P970004/S055 5/22/08 |
InterStim Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Modifications to the sterilization process. |
| D970012/S049 5/7/08 |
AMS 700™ Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change intended to steamline in-process inspection techniques. |
| D970012/S050 5/30/08 |
AMS 700™ & Ambicor Inflatable Penile Prosthesis (IPP) | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| D970012/S052 5/16/08 |
AMS 700™ Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change involving cytotoxicity testing. |
| D970012/S053 5/23/08 |
AMS Ambicor® Inflatable Penile Prosthesis | American Medical Systems Minnetonka, MN 55343 |
Change to the parameters used to condition a component of the device. |
| P970021/S018 5/12/08 |
Gynecare Thermachoice III Uterine Balloon Therapy System | Ethicon Women’s Health and Urology Somerville, NJ 08876 |
Modification to a test method. |
| P970021/S020 5/14/08 |
Gynecare Thermachoice III Uterine Balloon Therapy System | Ethicon Women’s Health and Urology Somerville, NJ 08876 |
Change in the supplier’s processing parameters for a tubing component. |
| P980016/S128 5/14/08 |
Secura DR/VR and Maximo II DR/VR Family of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to an inspection criteria for batteries used in implantable devices. |
| P980016/S129 5/14/08 |
CapSure Fix Dual Chamber ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P980035/S092 5/14/08 |
AT500 IPGs | Medtronic, Inc. Shoreview, MN 55126 |
Change the workstation used to weld the case-to-cover seam joint on batteries when manufacturing the AT500 IPG Model AT501. |
| P980050/S033 5/14/08 |
CS-SVC Transvene Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P990013/S019 5/30/08 |
STAAR® Surgical Collamer UV – Absorbing Posterior Chamber Intraocular Lens | STAAR® Surgical Monrovia, CA 91016 |
Replacing the old self-contained irradiator with a new unit of the same model. |
| P990014/S005 5/2/08 |
Meridian Intraocular Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Change in the limulus amebocyte lysate (LAL) testing method and a change in the site for the LAL final product testing to Bausch & Lomb, Inc.’s Clearwater, Florida facility. |
| P990023/S004 5/5/08 |
CELLUGEL® Ophthalmic Viscosurgical Devices | Alcon Research Ltd. Fort Worth, TX 76134 |
Use of an alternate analytical method for the identification of rubber formulations used in the syringe tip cap and stoppers. |
| P000007/S016 5/22/08 |
Prima Plus™ Stentless Aortic Bioprosthesis, Model 2500P | Edwards Lifesciences LLC Irvine, CA 92614 |
Change in suppliers for a polyester raw material used in the manufacture of the device. |
| P000029/S044 5/23/08 |
Deflux® Injectable Gel | Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Additional sterility testing laboratory. |
| P000032/S027 5/30/08 |
Her Option® Office Cryoablation Therapy System | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| P000037S013 5/12/08 |
On-X Prosthetic Heart Valve | On-X Life Technologies, Inc. Austin, TX 78754 |
Introduction of a second proof test unit. |
| P000043/S021 5/30/08 |
TherMatrx Office Thermotherapy System | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| P000053/S015 5/30/08 |
AMS 800 Artificial Urinary Sphincter | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| P010012/S177 5/19/08 |
RENEWAL Family of Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Add a second supplier for a component in the hybrid circuit. |
| P010012/S178 5/21/08 |
CONTAK RENEWAL Family of Heart Failure Pulse Generators (PGs) | Guidant Corporation St. Paul, MN 55112 |
Processing of additional product on existing bonder machines. |
| P010015/S043 5/14/08 |
Attain CS, Attain OTW, Attain Bipolar OTW Pacing Leads | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P010020/S009 5/30/08 |
Acticon Neosphincter Artificial Bowel Sphincter | American Medical Systems Minnetonka, MN 55343 |
Conversion of a part of the production system from a manual to a software automated operation. |
| P010031/S097 5/14/08 |
Consulta and Maximo II Cardiac Resynchronization Therapy Family of Devices | Medtronic, Inc. Mounds View, MN 55112 |
Modifications to an inspection criteria for batteries used in implantable devices. |
| P010031/S098 5/14/08 |
Attain SD Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P020009/S043 5/21/08 |
Express2™ Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to a test method and corresponding specifications for the tensile property of the balloon tube component. |
| P020026/S051 5/1/08 |
Cypher Sirolimus-Eluting Coronary Stent System | Cordis Corporation Miami, Lakes, FL 33014 |
Inclusion of the Cordis LLC San German site as an alternate bacterial endotoxin test (BET) testing facility. |
| P030009/S022 5/21/08 |
Driver and Micro-Driver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Change in the welding process. |
| P030016/S007 5/23/08 |
Visian Implantable Collamer Lens™ | STAAR Surgical, Co. Monrovia, CA 91016 |
Change to implement a new sterilization process. |
| P030017/S061 5/1/08 |
PRECISION® Spinal Cord Stimulator System | Boston Scientific Neuromodulation Sylmar, CA 91342 |
Change to the vacuum bake parameters. |
| P030025/S055 5/21/08 |
Taxus™ Express2™ Paclitaxel Eluting Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to a test method and corresponding specifications for the tensile property of the balloon tube component. |
| P030036/S006 5/14/08 |
Select Secure Pacing Lead | Medtronic, Inc. Mounds View, MN 55112 |
Change to the Rice Creek facility’s ethylene oxide (EtO) sterilization exposure time for leads, pacing accessories, and adaptor products. |
| P030054/S087 5/15/08 |
Epic HF CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change to the manufacturing process for the high-voltage hybrid assembly. |
| P040016/S030 5/21/08 |
Liberté™ Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to a test method and corresponding specifications for the tensile property of the balloon tube component. |
| P040024/S021 5/7/08 |
Restylane® Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85258 |
Change in sterility testing laboratory used in the manufacturing of Restylane® Injectable Gel. |
| P040048/S005 5/16/08 |
Trilogy AB Acetabular System | Zimmer, Inc. Warsaw, IN 46581 |
Change in the gamma sterilization dose verification method for the Trilogy AB acetabular System. |
| P050006/S006 5/7/08 |
GORE HELEX Septal Occluder | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Modification of the flaring pin used in the mandrel flaring process and the addition of the inspection criteria to the wire inspection procedure. |
| P060033/S003 5/16/08 |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Reuse of catheter hoops for the Endeavor Over-the-Wire (OTW), Multi-Exchange II (MX 2), and Rapid Exchange (RX) Coronary Stent Systems. |
| P060033/S004 5/13/08 |
Endeavor Zotarolimus-Eluting Coronary Stent System | Medtronic Vascular, Inc. Santa Rosa, CA 95403 |
Elimination of the “Final Inspection Pre-Clean” work step (pre-PC spray inspection) of the Phosphorylcholine (PC) Polymer Basecoat Spray Process for the Endeavor Zotarolimus-Eluting Coronary Stent System. |
| P060033/S005 5/21/08 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Change in the welding process. |
| P060033/S006 5/27/08 |
Endeavor Zotarolimus-Eluting Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 |
Alternate inner pouch sealing process. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 73
Summary of PMA Originals Under Review
Total Under Review: 74
Total Active: 37
Total On Hold: 37
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 439
Total Active: 265
Total On Hold: 174
Number Greater Than 180 Days: 12
Summary of All PMA Submissions Received
Originals: 1
Supplements: 121
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 73
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 149.4
FDA Time: 96.2 Days MFR Time: 53.2 Days
Updated August 20, 2008
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