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.
| P020056 11/17/06 |
Innamed® Silicone-Filled Breast Implants (Styles 10, 15, 20, 40, 45, 110, 11 and 120) | Allergan Santa Barbara , CA 93111 |
Approval for the Inamed® Silicone-Filled Breast Implants. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
| P030053 11/17/06 |
Mentor MemoryGel™ Silicone Gel-Filled Breast Implants (Moderate Profile Stye 7000, High Profile Style 4000, and Moderate Plus Profile Style 8000) | Mentor Corporation Santa Barbara , CA 93111 |
Approval for the Mentor MemoryGel™ Silicone Gel-Filled Breast Implants. This device is indicated for breast augmentation for women at least 22 years old and for breast reconstruction for women of any age. Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery. |
| P050031 11/16/06 |
Paragon Z CRT® (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy | Paragon Vision Sciences Mesa , AZ 85204 |
Approval for the Paragon Z CRT® (tisilfocon A) Rigid Gas Permeable Contact Lenses for Contact Lens Corneal Refractive Therapy. The lenses are indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear in the Contact Lens Corneal Refractive Therapy fitting program for the temporary reduction of myopia up to 6.00 diopters in eyes with astigmatism up to 1.75 diopters. The lenses may be disinfected using only a chemical disinfection system. NOTE: to maintain the Contact Lens Corneal Refractive Therapy effect of myopia reduction, overnight lens wear must be continued on a prescribed schedule. Failure to do so can affect daily activities (e.g., night driving), visual fluctuations and changes in intended correction. |
| P790018/S046 11/7/06 135-Day |
Medtronic Hall | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P800022/S053 11/3/06 180-Day |
Zyderm®/Zyplast® Collagen, CosmoDerm™/ CosmoPlast™ Human Collagen Implant | Inamed Corporation Santa Barbara , CA 93111 |
Approval for a sterilization site and method change located at Serigenics US, LLC, Corona, California. |
| P830045/S104 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P850089/S054 11/7/06 135-Day |
CapSure Pacing Leads | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P860004/S087 11/22/06 135-Day |
Medtronic® SynchroMed® II Implantable Programmable Infusion Pump System | Medtronic Neurological Minneapolis , MN 55432 |
Approval for changes to the electrical test specifications of the Model 8637 Pump. |
| P860057/S040 11/8/06 180-Day |
Carpentier-Edwards® PERIMOUNT® Pericardial Aortic Bioprosthesis Model 2700TFX; Carpentier-Edwards® PERIMOUNT® RSR Pericardial Aortic Bioprosthesis Model 2800TFX; Carpentier-Edwards® PERIMOUNT PLUS® Pericardial Mitral Bioprosthesis Model 6900PTFX | Edwards Lifesciences LLC Irvine , CA 92614 |
Approval for the trade name change for three devices, the Carpentier-Edwards® PERIMOUNT® pericardial aortic bioprosthesis model 2700TFX trade name change to the Carpentier-Edwards® PERIMOUNT Theon™ pericardial aortic bioprosthesis model 2700TFX , the Carpentier-Edwards® PERIMOUNT® RSR pericardial aortic bioprosthesis model 2800TFX trade name change to the Carpentier-Edwards® PERIMOUNT Theon™ RSR pericardial aortic bioprosthesis model 2800TFX, and the Carpentier-Edwards® PERIMOUNT PLUS® pericardial mitral bioprosthesis model 6900PTFX trade name change to the Carpentier-Edwards® PERIMOUNT Theon™ pericardial mitral bioprosthesis model 6900PTFX . The indications for the three devices remain unchanged. |
| P880006/S047 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P880086/S136 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P890003/S104 11/7/06 135-Day |
Legacy D, Legacy S, Legacy II, Visa, CapSure Pacing Leads | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P890003/S110 11/15/06 Real-Time |
Model 2490H Medtronic CareLink Monitor (Software reversions C and D) and Model 2491 DDMA Software (K7DDMA2 1v11 Revision A, K3DDMA 1v9 2491 Revision A, K2DDMA2 1v3 2491 Revision A, K9DDMA2 1v7 2491 Revision A, and Adapta xmlWaveformSection_kappa 5v6 Revision A) for Adapta Models ADDRL1, ADDR01, ADDR03, ADDR06, ADD01, ADVDD01, ADSR01, ADSR03, ADSR06, ADDRS1; Sensia Models SEDR01, SEDRL1, SED01, SESR01, SES01; and Versa Model VEDR01 | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Model 2490H Medtronic CareLink Monitor and Model 241 DDMA Software. |
| P890003/S112 11/29/06 Real-Time |
Medtronic Models 2490A (Rev. G)/ 2490C (Rev. K)/ 2490D (Rev. D)/ 2490D (Rev. K), 2490E (Rev. L)/ 2490G (Rev. G)/ 2490H (Rev. D)/ 2490J (Rev. F); Medtronic 2020A CardioSight Reader; and Medtronic 2030A Battery Check Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the MCI upgrade to include the Brady Enhancements. |
| P900060/S037 11/3/06 180-Day |
CarboMedics Prosthetic Heart Valve | CarboMedics, Inc. Austin , TX 78752 |
Approval for a manufacturing site located at Sorin Biomedica Cardio S.R.L., Saluggia ( Vercelli), Italy. |
| P900061/S065 11/7/06 135-Day |
Gem | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P900061/S069 11/29/06 Real-Time |
Medtronic Models 2490A (Rev. G)/ 2490C (Rev. K)/ 2490D (Rev. D)/ 2490D (Rev. K), 2490E (Rev. L)/ 2490G (Rev. G)/ 2490H (Rev. D)/ 2490J (Rev. F); Medtronic 2020A CardioSight Reader; and Medtronic 2030A Battery Check Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the MCI upgrade to include the Brady Enhancements. |
| P910023/S124 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P920015/S035 11/7/06 135-Day |
Sprint Leads, Tunneling Tools | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P930016/S026 11/3/06 Real-Time |
VISX STAR S4 IR™ Excimer Laser System and WaveScan® System | AMO/VISX, Inc. Santa Clara , CA 95051 |
Approval for an upgrade of the WaveScan® software to version 3.67 to correct a design flaw that led to an incorrect patient treatment being delivered, and to introduce an additional software check to mitigate treatment calculation errors. |
| P950021/S008 11/6/06 180-Day |
ADVIA IMS® Complexed Prostate Specific Antigen Assay (cPSA) | Bayer HealthCare LLC Diagnostics Division Tarrytown , NY 10591 |
Approval for a manufacturing site change located at Fisher Diagnostics, Middletown, Virginia. |
| P950024/S008 11/7/06 135-Day |
CapSure Epicardial Leads | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P960043/S060 11/21/06 Special |
Perclose® ProGlide™ 6 French Suture-Mediated Closure (SMC) Systems | Abbott Laboratories Redwood City , CA 94063 |
Approval for revised instructions for use. |
| P970012S023 11/7/06 135-Day |
Kappa 400 | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| D970012/S032 11/22/06 Special |
AMS Model 700™ Inflatable Penile Prosthesis | American Medical Systems, Inc. Minnetonka , MN 55343 |
Approval for amendments to the Operating Room Manual. |
| P970013/S014 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P970043/S026 11/1/06 Real-Time |
LADARVision® 4000 and LADAR6000™ Excimer Laser Systems and the CustomCornea® Surgery Planning Software | Alcon Laboratories, Inc. Orlando , FL 32826 |
Approval for a software change to the wavefront-image gathering sequence in the CustomCornea® Surgery Planning Software to allow for different pre-op and surgery days; a change to the LADAR6000™ software to allow for conventional centration photos to be imported from the LADARWave® CustomCornea® Wavefront system; and, minor enhancements/bug fixes to the LADARVision® 4000 software, the LADAR6000™ System software, and the CustomCornea® Surgery Planning Software. |
| P970053/S010 11/8/06 180-Day |
Nidek EC-5000 Excimer Laser System Model CXIII | Nidek Company, LTD Gamagoriaichi , Japan |
Approval for modifications to the Nidek EC-5000 Excimer Laser System (Model CXII) including a reduction in size, the standardization of previously optional features, incorporating the control computer into the computer (previously stand-alone) and replacing the original (manual magnification) microscope with a new model with motorized magnification control. The new device will be named the Nidek EC-5000 Excimer Laser System Model CXIII. |
| P980016/S074 11/7/06 135-Day |
Onyx VR, Marquis DR, Marquis VR, Maximo DR, Maximo VR, Intrinsic 30, Intrinsic, EnTrust 30J/35J, Gem DR, Gem II VR, Gem II DR, Gem III VR, Gem III DR, CapSure Fix, Virtuoso DR, Virtuoso VR | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P980016/S084 11/15/06 Real-Time |
Medtronic® Virtuoso™ Model D154AWG/ D154VWC Implantable Devices | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software version 1.1 which addresses an issue of temperature sensitivity on telemetry. |
| P980016/S086 11/15/06 Real-Time |
Tantalum Capacitor (XTC018) for the Marquis DR/VR Models 7274, 7230B, 7230Cx, 7230E; Maximo DR/VR Models 7278, 7232B, 7232Cx, 7232E, Intrinsic 30/Intrinsic Models 7287, 7288; EnTrust D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC; Virtuoso D154AWG, D154VWC | Medtronic, Inc. Cardiac Rhythm Management Minneapolis , MN 55432 |
Approval for the design change to add alternate Tantalum capacitor (XTC018) on the hybrid of the Medtronic ICDs. |
| P980016/S089 11/29/06 Real-Time |
Medtronic Models 2490A (Rev. G)/ 2490C (Rev. K)/ 2490D (Rev. D)/ 2490D (Rev. K), 2490E (Rev. L)/ 2490G (Rev. G)/ 2490H (Rev. D)/ 2490J (Rev. F); Medtronic 2020A CardioSight Reader; and Medtronic 2030A Battery Check Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the MCI upgrade to include the Brady Enhancements. |
| P980035/S057 11/7/06 135-Day |
Kappa 700, Vitatron, Kappa 900, EnPulse, Sigma, Medtronic 350 Series, EnRhythm, AT500 |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P980035/S063 11/15/06 Real-Time |
Model 2490H Medtronic CareLink Monitor (Software reversions C and D) and Model 2491 DDMA Software (K7DDMA2 1v11 Revision A, K3DDMA 1v9 2491 Revision A, K2DDMA2 1v3 2491 Revision A, K9DDMA2 1v7 2491 Revision A, and Adapta xmlWaveformSection_kappa 5v6 Revision A) for Adapta Models ADDRL1, ADDR01, ADDR03, ADDR06, ADD01, ADVDD01, ADSR01, ADSR03, ADSR06, ADDRS1; Sensia Models SEDR01, SEDRL1, SED01, SESR01, SES01; and Versa Model VEDR01 | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the Model 2490H Medtronic CareLink Monitor and Model 241 DDMA Software. |
| P980035/S066 11/29/06 Real-Time |
Medtronic Models 2490A (Rev. G)/ 2490C (Rev. K)/ 2490D (Rev. D)/ 2490D (Rev. K), 2490E (Rev. L)/ 2490G (Rev. G)/ 2490H (Rev. D)/ 2490J (Rev. F); Medtronic 2020A CardioSight Reader; and Medtronic 2030A Battery Check Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the MCI upgrade to include the Brady Enhancements. |
| P980037/S015 11/21/06 Real-Time |
AngioJet® Ultra Thrombectomy System (XMI Catheter) | Possis Medical, Inc. Minneapolis , MN 55433 |
Approval for minor changes to the XMI Catheter. |
| P980050/S023 11/7/06 135-Day |
Gem III AT, Transvene | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P990052/S013 11/2/06 135-Day |
Vibrant Soundbridge | MED-EL Corporation Durham , NC 27713 |
Approval to establish a second source supplier for the Demodulator housing (implant electronics case). |
| P990055/S009 11/6/06 180-Day |
ADVIA IMS® Prostate Specific Antigen Assay (PSA) | Bayer HealthCare LLC Diagnostics Division Tarrytown , NY 10591 |
Approval for a manufacturing site change located at Fisher Diagnostics, Middletown, Virginia. |
| P000041/S005 11/1/06 180-Day |
RapidScreen RS-2000D | Riverain Medical Group Miamisburg , OH 45342 |
Approval for design changes to the RapidScreen RS-2000D to provide reduced number of false positives per image with a statistically insignificant impact on the detection sensitivity. |
| P010015/S023 11/7/06 135-Day |
InSync III, InSync, Attain | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P010030/S007 11/1/06 Real-Time |
LifeVest WCD 3100 | Lifecor, Inc. Pittsburgh , PA 15238 |
Approval for hardware change to integrate the pendant Alarm Module into the monitor enclosure, hardware change to the Computer/Analog printed circuit assembly to improve EMI immunity and replace several obsolete components, software changes to interact with the revised Computer/Analog printed circuit assembly, labeling changes to accommodate the integrated Alarm module, and to improve readability, labeling changes to provide a Spanish version of the patient manual, patient checklist, and corresponding audio/display messages for Spanish speaking patients. The device, as modified, will be marketed under the trade name LifeVest WCD 3100 and is indicated for adult patients who are at risk of sudden cardiac arrest and are not candidates for or refuse an implantable defibrillator. |
| P010031/S041 11/7/06 135-Day |
InSync ICD, InSync Marquis, InSync II Marquis, InSync III Marquis, InSync II Protect, InSync III Protect, InSync Sentry, InSync Maximo, Concerto |
Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P010031/S051 11/15/06 Real-Time |
Medtronic® Concerto™ Model C154DWK Implantable Cardioverter Defibrillator | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for software version 1.1 which addresses an issue of temperature sensitivity on telemetry. |
| P010031/S053 11/15/06 Real-Time |
Tantalum Capacitor (XTC018) for the InSync Marquis Model 7277; InSync II Marquis Model 7289; InSync III Marquis Model 7279; InSync II Protect Model 7295; InSync Maximo 7303, 7304; InSync Sentry 7297, 7298, 7299; and Concerto C154DWK |
Medtronic, Inc. Cardiac Rhythm Management Minneapolis , MN 55432 |
Approval for the design change to add alternate Tantalum capacitor (XTC018) on the hybrid of the Medtronic ICDs. |
| P010031/S056 11/29/06 Real-Time |
Medtronic Models 2490A (Rev. G)/ 2490C (Rev. K)/ 2490D (Rev. D)/ 2490D (Rev. K), 2490E (Rev. L)/ 2490G (Rev. G)/ 2490H (Rev. D)/ 2490J (Rev. F); Medtronic 2020A CardioSight Reader; and Medtronic 2030A Battery Check Monitor | Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the MCI upgrade to include the Brady Enhancements. |
| P020026/S023 11/9/06 135-Day |
Cordis CYPHER® Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Approval for a change involving use of a new contractor for quality control testing. |
| P020047/S005 11/21/06 135-day |
MULTI-LINK RX and OTW VISION and MINI VISION Coronary Stent Systems | Abbott Vascular Temecula , CA 92591 |
Approval for a change to the type of laser used to cut the stents. |
| P030004/S002 11/29/06 180-Day |
Onyx Liquid Embolic System | ev3 Neurovascular Company Irvine , CA 92618 |
Approval for a manufacturing site located in Irvine, California. |
| P030017/S015 11/17/06 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System | Advanced Bionics Sylmar , CA 91342 |
Approval for the Implanted Pulse Generator (IPG) 2.2. |
| P030019/S012 11/8/06 180-Day |
Orthovisc® High Molecular Weight Hyaluronan | Anika Therapeutics, Inc. Woburn , MA 01801 |
Approval for elimination of the second sterilization step from the final packaging process, and an update to the package labeling to reflect this change. |
| P030035/S026 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P030036/S001 11/7/06 135-Day |
Select Secure | Medtronic, Inc. Shoreview , MN 55126 |
Approval for the addition of a paperless chart recorder to the sterilization operations. |
| P030039/S002 11/3/06 180-Day |
CoSeal Surgical Sealant Premixed | Baxter Healthcare Corporation McGaw Park , IL 60085 |
Approval for a manufacturing site located at Baxter Healthcare Corporation, Hayward, California. |
| P030047/S001 11/16/06 180-Day |
Cordis PRECISE® OTW 5.5 Fr and 6.0 Fr Nitinol Stent System | Cordis Corporation Warren , NJ 07059 |
Approval for the PRECISE® RX Nitinol Stent System. |
| P030054/S043 11/30/06 180-Day |
Epic HF/Atlas+HF Family of CRT-DS; Frontier/Frontier II Family of CRT-PS; Cadence Family of ICDs; Affinity/Integrity/Victory Family of Pacemakers; Sensolog/Dialog/Regency Family of Pacemakers; Microny Family of Pacemakers Pacemaker Programmer; Paragon/Phoenix Family of Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sylmar , CA 91342 |
Approval for the Model 3330 Version 5.2 Software for use on the Model 3650 Merlin Patient Care System and the Model 3307 Version 6.3.2 Software for use on the Model 3510 and 3500 Programmers. |
| P040002/S007 11/1/06 Real-Time |
Endologix PowerLink® System | Endologix, Inc. Irvine , CA 92618 |
Approval for modifications to the contralateral limb cover/guidewire assembly. |
| P040014/S003 11/13/06 180-Day |
Therapy Ablation Catheter and IBI1500T Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine , CA 92614 |
Approval for bi-directional functionality design modifications to the Therapy Ablation Catheter. |
| P040021/S005 11/14/06 180-Day |
St. Jude Medical Biocor® Valve and Biocor® Supra Valve | St. Jude Medical, Inc. St. Paul , MN 55117 |
Approval of the post-approval study. |
| P040022/S002 11/1/06 180-Day |
Angiolink Vascular Closure System | Medtronic Vascular Taunton , MA 02780 |
Approval for a manufacturing site located at STD MED, Inc., Stoughton, Massachusetts. |
| P040034/S003 11/17/06 180-Day |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham , MA 02451 |
Approval for an additional manufacturing site at Millstone Medical Outsourcing, LLC, Fall River, Massachusetts and an additional sterilization site at BeamOne, LLC, Lima, Ohio. |
| P040034/S007 11/2/06 Real-Time |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham , MA 02451 |
Approval for use of data collected at elevated temperatures (i.e., accelerated aging data) to determine future shelf life claims for the device, applying a correlation factor of Q 10=3. The use of the correlation factor with test data obtained at 35 ° C collected out to 26 weeks accurately predicts product expiration dating to 18 months, real-time. |
| P040038/S006 11/21/06 135-Day |
Xact® Carotid Stent System | Abbott Vascular Devices Redwood City , CA 94063 |
Approval to 1) tighten the connector inner diameter specification tolerance; and 2) modify the stent heat treatment process. |
| P810006/S024 11/8/06 |
CollaStat Absorbable Collagen Hemostatic Agents | Integra Plainsboro , NJ 08536 |
Change in manufacturing equipment used in the collagen purification process. |
| P840062/S011 11/8/06 |
CollaCote Absorbable Collagen Wound Dressing | Integra Plainsboro , NJ 08536 |
Change in manufacturing equipment used in the collagen purification process. |
| P850010/S021 11/8/06 |
Helistate Absorbable Collagen Hemostatic Agents | Integra Plainsboro , NJ 08536 |
Change in manufacturing equipment used in the collagen purification process. |
| P880047/S011 11/21/06 |
INTERCEED® Absorbable Adhesion Barrier | Ethicon, Inc. Somerville , NJ 08876 |
Change in the packaging material. |
| P880086/S135 11/9/06 |
Solus, Addvent, Solus II, Synchrony, Phoenix III, Trilogy, Affinity, Integrity, Entity, Identity, Verity and Victory Pacemakers | St. Jude Medical, Inc. Sylmar , CA 91342 |
Modification to the manufacturing software used to initialize the Victory family of pacemakers. |
| P880086/S137 11/21/06 |
Affinity, Integrity, and Victory Family of Pacemakers | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Elimination of the extra perimeter staking epoxy at final assembly on the LV hybrid and cover support interface on all Affinity, Integrity, Identity, Victory and Frontier family of devices. |
| P880086/S138 11/29/06 |
Victory Family of Pulse Generators | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Additional hybrid screening test. |
| P900009/S024 11/1/06 |
Exogen 4000+ Sonic Accelerated Fracture Healing System (SAFHS) | Smith & Nephew, Inc. Memphis , TN 38116 |
Addition of SAFT America, Inc., Valdese, North Carolina, as a new contract vendor for the manufacturing of battery packs for the referenced device. |
| P900033/S014 11/8/06 |
INTEGRA Dermal Regeneration Template | Integra Plainsboro , NJ 08536 |
Change in manufacturing equipment used in the collagen purification process. |
| P900061/S067 11/15/06 |
Gem | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P910023/S123 11/16/06 |
Cadence Family of ICDs & Epic Family of CRT-Ds | St. Jude Medical, Inc. Sylmar , CA 91342 |
Use of an automated soldering process to join the HV Capacitor wires to the High Voltage Printed Circuit Board Assembly connector pads, as an alternate to the existing manual soldering process. |
| P910023/S125 11/21/06 |
Cadence Family of ICDs | St. Jude Medical, Inc. Sylmar , CA 91342 |
Modifications to the ICD manufacturing software. |
| P950020/S020 11/15/06 |
Flextome Cutting Balloon Monorail | Boston Scientific San Diego, CA 92123 |
Lowering of the range of air pressure supplied to an EFD dispenser. |
| P950022/S031 11/15/06 |
Riata Family of Leads | St. Jude Medical, Inc. Sylmar , CA 91342 |
Alternate supplier of the DR-1 boot component. |
| P970003/S072 11/2/06 |
VNS Therapy System | Cyberonics, Inc. Houston , TX 77058 |
Reprocessing of the NCP Programming Wands for Model 201. |
| P970003/S073 11/2/06 |
VNS Therapy System | Cyberonics, Inc. Houston , TX 77058 |
Reprocessing of the handheld computers for the VNS Therapy System, Model 250 Programming Software. |
| D970003/S079 11/21/06 |
DISCOVERY, INSIGNIA, INTELIS, NEXUS, PULSAR, PULSAR MAX AND VIRTUS |
Guidant Corporation St. Paul , MN 55112 |
Changes to the adhesive for bonding the outer sleeves and seal plugs to the device header. |
| P970012/S025 11/15/06 |
Kappa 400 | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P980016/S087 11/15/06 |
Marquis DR, Marquis VR, InSync Marquis, InSync II Marquis, InSync III Marquis, Maximo DR, Maximo VR, Entrust 30J/35J, Onyx VR, Virtuoso Gem DR, Gem II VR, Gem II DR, Gem III AT, Gem IIIVR, Gem III DR |
Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P980035/S064 11/15/06 |
Kappa 700, Kappa 900, EnPulse, Adapta/Versa/ Sensia, Sigma, Medtronic 350 Series, EnRhythm, AT500 |
Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P980050/S025 11/15/06 |
Jewel AF, Gem II AT | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P990001/S027 11/15/06 |
Selection AFm, Clarity DDDR, Clarity SSIR, Diamond 3, Ruby 3, Topaz 3, Jade 3, Vita 2 DDDR, Vita 2, C60 DR, C20 SR, T60 DR, T20 SR, C60 DR, C20 SR | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P990080/S010 11/8/06 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lenses, CeeOn Models 91A and 913A and Tecnis Models Z9000 and Z900 | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change in he pouch in which the IOL lens tray is packaged; and a change in the synthesis process of the polymers. |
| P990080/S011 11/8/06 |
Foldable Ultraviolet Light-Absorbing Posterior Chamber Intraocular Lenses, CeeOn Models 91A and 913A and Tecnis Models Z9000 and Z900 | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change in he pouch in which the IOL lens tray is packaged; and a change in the synthesis process of the polymers. |
| P990080/S012 11/6/06 |
Foldable Ultraviolet-Absorbing Posterior Chamber intraocular Lenses, CeeOn Models 911A and 913A and Tecnis Models Z9000 and Z9001 | Advanced Medical Optics, Inc. Santa Ana , CA 92705 |
Change to the cleaning method for the static mixers. |
| P010015/S025 11/15/06 |
InSync, InSync III | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P010031/S054 11/15/06 |
InSync II Protect, InSync III Protect, Intrinsic 30, Intrinsic, InSync Sentry, InSync Maximo, Concerto | Medtronic, Inc. Shoreview , MN 55126 |
Reduction in the number of seamweld penetration monitoring samples and a minor modification in processing of seamweld data. |
| P020018/S021 11/29/06 |
Zenith® AAA Endovascular Graft with H&L-B One-Shot™ Introduction System | Cook, Inc. Bloomington , IN 47402 |
Change to the silicone lubricant used during manufacture of the device. |
| P020026/S028 11/29/06 |
CYPHER® Sirolimus-Eluting Coronary Stent | Cordis Corporation Miami Lakes , FL 33014 |
Change in the environmental conditions of the manufacturing facility. |
| P020036/S006 11/9/06 |
S.M.A.R.T. CONTROL Nitinol Stent System | Cordis Corporation Warren , NJ 07059 |
Modification of the acceptance criterion for a production inspection for the S.M.A.R.T. CONTROL Nitinol Stent System. |
| P030009/S007 11/21/06 |
Driver and MicroDriver Coronary Stent Systems | Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Reduction in the number of test samples for various Quality Control tests for the Driver MX 2 Coronary Stent System. |
| P030035/S027 11/21/06 |
Frontier/Frontier II Family of CRT-Ps | St. Jude Medical, Inc. Cardiac Rhythm Management Division Sylmar , CA 91342 |
Elimination of the extra perimeter staking epoxy at final assembly on the LV hybrid and cover support interface on all Affinity, Integrity, Identity, Victory and Frontier family of devices. |
| P030054/S042 11/16/06 |
Cadence Family of ICDs & Epic Family of CRT-Ds | St. Jude Medical, Inc. Sylmar , CA 91342 |
Use of an automated soldering process to join the HV Capacitor wires to the High Voltage Printed Circuit Board Assembly connector pads, as an alternate to the existing manual soldering process. |
| P030054/S044 11/21/06 |
Epic HF Family of Cardiac Resynchronization Therapy Devices | St. Jude Medical, Inc. Sylmar , CA 91342 |
Modifications to the ICD manufacturing software. |
| P040013/S008 11/17/06 |
GEM 21S® Growth Factor Enhanced Matrix | Biomimetic Therapeutics, Inc. Franklin , TN 37067 |
Add AAI Pharma-Wilmington facility as a qualified facility to conduct a bioassay on the drug component of the device. |
Summary of PMA Originals & Supplements Approved
Originals: 3
Supplements: 59
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 35
Total On Hold: 44
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 422
Total Active: 220
Total On Hold: 202
Number Greater Than 180 Days: 15
Summary of All PMA Submissions Received
Originals: 3
Supplements: 87
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 59
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 114.5
FDA Time: 74.8 Days MFR Time: 39.7 Days
Updated January 17, 2007
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