Post-Approval Studies

• In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
• The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
• CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
• In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• IRB Letter from Dr. Schultz (dated 2/9/09)

Contact Information

Nicole Jones
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4108
Silver Spring, MD
20993-0002

Phone: (301) 796-6062
Fax: (301) 847-8140
nicole.jones@fda.hhs.gov

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Show All Studies Export to Excel Application Number Applicant Name    Device Name Medical Specialty Date PMA Approved Study Name Study Status P040038 ABBOTT VASCULAR DEVICES XACT CAROTID STENT SYSTEM Cardiovascular 09/06/2005 PROTECT Study Progress Adequate EXACT Study Completed P070015 ABBOTT VASCULAR INC. XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 07/02/2008 Longterm IDE Follow up Study Pending XIENCE Registry Progress Adequate Dual Antiplatelet Therapy Progress Inadequate Fatigue Testing Study Pending H040006 ABIOMED, INC. ABIOCOR Cardiovascular 09/05/2006 Abiocor Artificial Heart Progress Inadequate P040040 AGA MEDICAL CORP. AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 5 year long term (IDE) Progress Inadequate 5 year registry Progress Inadequate P020056 ALLERGAN NATRELLE SILICONE-FILLED BREAST IMPLANTS General & Plastic Surgery 11/17/2006 BIFS (Large PAS) Progress Inadequate Core Progress Inadequate Adjunct Progress Inadequate Device failure Study Progress Adequate Informed Decision Process Progress Adequate P000053 S005 AMERICAN MEDICAL SYSTEMS, INC. SPHINCTER 800 URINARY CONTROL SYSTEM Gastroenterology/ Urology 10/13/2006 Registry AMS MC-0611 Progress Adequate P050033 ANIKA THERAPEUTICS, INC. ELEVESS General & Plastic Surgery 12/20/2006 Elevess CTA Study Progress Inadequate P060025 ATS MEDICAL, INC. ATS 3F AORTIC BIOPROSTHESIS Cardiovascular 10/30/2008 ATS 3f Study Pending P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 RESILIENT Study Pending CONTINUIM Study Pending P050037 BIOFORM MEDICAL, INC. RADIESSE 1.3CC AND 0.3CC General & Plastic Surgery 12/22/2006 Radiesse Completed P050052 BIOFORM MEDICAL, INC. RADIESSE 1.3CC AND 0.3CC General & Plastic Surgery 12/22/2006 Long Term (Nasolabial Folds) Completed Short Term (Fitzpatrick) Completed P040047 BIOFORM MEDICAL, INC. COAPTITE Gastroenterology/ Urology 11/10/2005 Coaptite Progress Inadequate P020016 BIOMET MICROFIXATION, INC. WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM Dental 09/21/2005 Longterm Followup Study Progress Adequate P050009 BIOMET, INC. C2 A-TAPER ACETABULAR SYSTEM Orthopedic 12/16/2005 Long Term Study Protocol Pending P040013 S009 BIOMIMETIC THERAPEUTICS, INC. GEM 21S (GROWTH ENHANCED MATRIX) Dental 08/10/2007 Working Standard for Biomatrix Completed P040036 BIOSENSE WEBSTER, INC. NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Cardiovascular 08/11/2006 NaviStar Study Progress Adequate P030031 S011 BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 CABANA Trial Protocol Pending Atrial Fibrillation Registry Study Pending P070008 BIOTRONIK, INC. STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD Cardiovascular 05/12/2008 CELESTIAL Study Progress Adequate P050023 BIOTRONIK, INC. TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEAD Cardiovascular 08/10/2006 COROX LEAD Progress Adequate TUPOS LV Completed P050025 BOSTON SCIENTIFIC CORP. ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM Cardiovascular 10/27/2006 CABERNET Registry Completed SONOMA Progress Adequate P030025 S021 BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM Cardiovascular 09/24/2008 5 year clinical outcomes Study Pending Fatigue/Matter Testing Study Pending P050019 BOSTON SCIENTIFIC CORP. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS Cardiovascular 10/23/2008 CABANA REGISTRY Progress Adequate BEACH STUDY Completed P060006 BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM Cardiovascular 12/11/2008 BSC Express PAS Progress Adequate P060008 BOSTON SCIENTIFIC CORP. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 Outcomes TAXUS ATLAS Protocol Pending TAXUS Registry Progress Inadequate Dual Antiplatelet Study Protocol Overdue Fatigue & Stability Testing Study Pending P030025 S028 BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) Cardiovascular 09/24/2008 5 year Clincal Outcomes Progress Adequate Matter Testing Study Pending P060008 S008 BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 05/21/2009 TAXUS ATLAS Small Vessel Study Pending P060008 S011 BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 07/13/2009 Clinical Outcomes Progress Adequate P060002 C.R. BARD, INC. FLAIR ENDOVASCULAR STENT GRAFT Cardiovascular 07/23/2007 FLAIR Endovascular Grafts Progress Adequate P970051 S028 COCHLEAR AMERICAS NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/01/2005 Pediatric Study Progress Inadequate P070013 COLBAR LIFESCIENCE LTD. EVOLENCE COLLAGEN FILLER General & Plastic Surgery 06/27/2008 EVOLENCE Progress Adequate P020014 S012 CONCEPTUS, INC. CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/ Gynecology 06/15/2007 ESS-305 Progress Adequate P040034 CONFLUENT SURGICAL,INC DURASEAL DURAL SEALANT SYSTEM Neurology 04/07/2005 Duraseal Progress Adequate P020018 S005 COOK, INC. ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 06/09/2005 Postmarket Surveillance Registry Progress Adequate P020018 S010 COOK, INC. 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT Cardiovascular 09/07/2006 AAA Flex 36mm Progress Adequate P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 Long Term Study Progress Adequate New Enrollment Progress Inadequate P970003 S050 CYBERONICS, INC. VNS THERAPY SYSTEM Neurology 07/15/2005 Registry Study Progress Inadequate Dosing Study D-21 Progress Inadequate P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term Protocol Pending P860057 S023 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX Cardiovascular 04/07/2005 Carpentier Edwards PAS Progress Adequate P860057 S029 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term Progress Adequate P860057 S042 EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 Clinical Study Protocol Pending P060027 ELA MEDICAL, INC. OVATIO CRT SYSTEM Cardiovascular 05/15/2008 Long Term Progress Adequate P980049 S020 ELA MEDICAL, INC. OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD Cardiovascular 04/28/2006 Ovatio DR6550 Study Progress Adequate P970021 S014 ETHICON WOMEN'S HEALTH & UROLOGY GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM Obstetrics/ Gynecology 07/06/2007 Long-Term Study Progress Adequate P060001 EV3 INC PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS Cardiovascular 01/24/2007 CREATE PAS Progress Adequate CREATE (IDE) Completed P030004 EV3 NEUROVASCULAR ONYX LIQUID EMBOLIC SYSTEM Neurology 07/21/2005 Long Term Study Completed P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Long Term Protocol Pending P010012 S160 GUIDANT CORP. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 ACUITY Long-Term Registry Study Pending P080014 HOLOGIC, INC. CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT Microbiology 03/12/2009 PAS Study Pending P080015 HOLOGIC, INC. CERVISTA HPV 16/18 Microbiology 03/12/2009 PAS Study Pending P070022 HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM Obstetrics/ Gynecology 07/06/2009 PAS Study Pending H070004 LEVITRONIX LLC. LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) Cardiovascular 10/07/2008 Centrimag PAS Study Pending P060039 MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 Chronic Extraction Study Pending Chronic Performance Study Progress Adequate P980035 S073 MEDTRONIC INC. MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE Cardiovascular 05/13/2008 Longterm Study PAS Progress Adequate P890003 S119 MEDTRONIC INC. CARELINK MONITOR MODEL 2490H Cardiovascular 05/13/2008 Longterm PAS Progress Adequate P010031 S104 MEDTRONIC INC. CONCERTO/INSYNC SENTRY/INSYNC MAXIMO Cardiovascular 08/28/2008 Enhanced Surveillance Study Pending P980016 S135 MEDTRONIC INC. VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR Cardiovascular 08/28/2008 Enhanced Surveillance Study Pending P080006 MEDTRONIC INC. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 Elution Study Pending Chronic Lead Performance Study Pending P980022 S012 MEDTRONIC MINIMED GUARDIAN RT Clinical Chemistry 08/24/2005 PXX/GS041/A Completed P060018 MEDTRONIC SOFAMOR DANEK USA, INC. PRESTIGE CERVICAL DISC SYSTEM Orthopedic 07/16/2007 Long-Term Study Progress Adequate Enhanced Surveillance Progress Adequate P060023 MEDTRONIC SOFAMOR DANEK USA, INC. BRYAN CERVICAL DISC PROSTHESIS Orthopedic 05/12/2009 Long-Term Study Study Pending Enhanced Surveillance Study Pending P040001 MEDTRONIC SPINE LLC. X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM Orthopedic 11/21/2005 LTOS Study Progress Adequate COAST Study Progress Adequate P060033 MEDTRONIC VASCULAR ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 02/01/2008 5yr Clinical Outcomes Progress Adequate Registry PROTECT CA Progress Adequate Dual Antiplatelet Therapy Progress Inadequate Product Testing Study Pending P070007 MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM Cardiovascular 06/05/2008 THRIVE Trial Progress Inadequate P070012 MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM Cardiovascular 10/23/2007 MAVErIC II Long Term Study Completed EMERGE Terminated P070027 MEDTRONIC VASCULAR THE TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 04/15/2008 Vitality Trial Progress Adequate P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General & Plastic Surgery 11/17/2006 Large PAS Progress Adequate Device Failure Study Progress Adequate Informed Decision Process Progress Adequate Adjunct Study Progress Inadequate Core Progress Adequate P040052 MONOGEN, INC. MONOPREP PAP TEST Pathology 03/03/2006 CHOICE Study Other P000049 S016 NMT MEDICAL, INC. STARFLEX SEPTAL OCCLUSION SYSTEM Cardiovascular 03/05/2009 Fatigue & Corrosion Testing Study Pending P070009 OBTECH MEDICAL GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X Gastroenterology/ Urology 09/28/2007 Realize PAS Study Pending P040025 OLYMPIC MEDICAL CORP. OLYMPIC COOL-CAP Neurology 12/20/2006 VON Registry Progress Adequate P050031 PARAGON VISION SCIENCES PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY Ophthalmic 11/16/2006 Paragon PAS Progress Adequate P030050 S002 SANOFI AVENTIS U.S. LLC SCULPTRA AESTHETIC General & Plastic Surgery 07/28/2009 PAS Progress Adequate P050050 SMALL BONE INNOVATIONS, INC. SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 Long Term Study Protocol Pending Prospective MultiCenter Study Protocol Pending P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study Progress Adequate UK Study Progress Adequate P040028 SPECTRA SCIENCE LUMA CERVICAL IMAGING SYSTEM Obstetrics/ Gynecology 03/16/2006 LUMA Progress Inadequate H060002 SPIRATION, INC. IBV VALVE SYSTEM General & Plastic Surgery 10/24/2008 IBV Valve Protocol Pending P030054 S067 ST. JUDE MEDICAL ATLAS II + HF CRT-D SYSTEM Cardiovascular 01/13/2009 PAS Study Pending P950022 S042 ST. JUDE MEDICAL, INC. RIATA ST OPTIM AND RIATA STS OPTIM Cardiovascular 01/13/2009 PAS Study Pending P910023 S154 ST. JUDE MEDICAL, INC. PROMOTE CRT-D SYSTEM Cardiovascular 01/13/2009 PAS Study Pending P040021 ST. JUDE MEDICAL, INC. SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE Cardiovascular 08/05/2005 Biocor & Biocor Supra Valves Progress Inadequate P030016 STAAR SURGICAL CO. VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 Adverse Event Study Progress Inadequate Follow up Study Protocol Pending Axial Lengths Progress Inadequate P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Long term Protocol Pending P020012 SUNEVA MEDICAL, INC. ARTEFILL General & Plastic Surgery 10/27/2006 Study P521-01 Progress Adequate P070005 SYNTHEMED CORP. REPEL-CV BIORESORBABLE ADHESION BARRIER Cardiovascular 03/06/2009 REPEL CV Study Pending P070001 SYNTHES SPINE PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 Long Term Study Progress Adequate Enhanced Surveillance Study Progress Adequate P050010 SYNTHES SPINE PRODISC -L TOTAL DISC REPLACEMENT DEVICE Orthopedic 08/14/2006 PRODISC-L Long Term Study Progress Adequate P060040 THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 04/21/2008 INTERMACS Registry Progress Adequate P870072 S037 THORATEC CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 Thoratec TLC-ii portable Progress Adequate P040050 UROPLASTY, INC. MACROPLASTIQUE IMPLANTS Gastroenterology/ Urology 10/30/2006 5 year registry - ROSE Progress Adequate Enhanced Surveillance Completed P060017 VERIDEX, LLC GENESEARCH BREAST LYMPH NODE(BLN) ASSAY Immunology 07/16/2007 PPC Study Progress Inadequate TS Study Progress Inadequate P930016 S025 VISX, INCORPORATED STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM Ophthalmic 07/11/2007 Star 4 Monovision Lasik Other P040043 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 03/23/2005 Cohort Study Progress Adequate Training Study Completed P050006 W.L. GORE & ASSOCIATES,INC GORE HELEX SEPTAL OCCLUDER Cardiovascular 08/11/2006 GORE HELEX Progress Adequate P070016 WILLIAM COOK EUROPE APS ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 05/21/2008 Longterm PAS Study Pending P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Long term Protocol Pending P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 Long Term Study Progress Adequate

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