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U.S. Department of Health and Human Services

Post-Approval Studies

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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

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov
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To sort by data column: 227 records  
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Name
Most Recent
Protocol
Version
Approved
Study Status
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 Long term 06/28/2006 Revised/Replaced Study
Trilogy PAS 06/04/2010 Terminated
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 Long Term Study 11/06/2008 Progress Inadequate
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 11/26/2008 Progress Adequate
P050006 W.L. GORE & ASSOCIATES,INC GORE HELEX SEPTAL OCCLUDER Cardiovascular 08/11/2006 GORE HELEX 08/11/2006 Progress Adequate
P040043
S051
W.L. GORE & ASSOCIATES,INC GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 TAG Post-Approval Study Protocol Pending
P040037
S050
W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE Cardiovascular 10/18/2013 Extended F/u 25cm Viabahn Endoprosthesis 10/18/2013 Progress Adequate
P040043 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 03/23/2005 Training Study 08/31/2005 Completed
Cohort Study 08/31/2005 Progress Adequate
P930016
S025
VISX, INCORPORATED STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM Ophthalmic 07/11/2007 Star 4 Monovision Lasik 04/02/2008 Other
P050034 VISION CARE OPHTHALMIC TECHNOLOGIES, LTD. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 IMT PAS 01 New Enrollment Study 10/07/2010 Progress Adequate
Premarket Cohort IMT-002-LTME 10/13/2010 Completed
P060017 VERIDEX, LLC GENESEARCH BREAST LYMPH NODE(BLN) ASSAY Pathology 07/16/2007 TS Study 10/29/2007 Other
PPC Study 10/29/2007 Other
P030050
S002
VALEANT INTERNATIONAL (BARBADOS) SRL SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 Pre Clinical PAS 09/09/2010 Completed
Clinical PAS 04/23/2014 Study Pending
P040050 UROPLASTY, INC. MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology
10/30/2006 5 year registry - ROSE 10/30/2006 Progress Adequate
Enhanced Surveillance 10/30/2006 Completed
P120006 TRIVASCULAR INC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 Long Term Follow-up Study 06/21/2013 Progress Inadequate
Training Program 08/28/2013 Progress Inadequate
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology
03/22/2012 Enrollment Study 06/22/2012 Progress Adequate
Extended f/u of premarket cohort 06/22/2012 Progress Adequate
P870072
S037
THORATEC CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 Thoratec TLC-ii portable 11/14/2007 Progress Adequate
P060040 THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 04/21/2008 INTERMACS Registry 04/21/2008 Completed
H070004 THORATEC CORP. CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) Cardiovascular 10/07/2008 Centrimag PAS 05/22/2009 Progress Adequate
P060040
S005
THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 01/20/2010 Destination Therapy-INTERMACS 05/07/2010 Completed
Heartmate II Bleeding Study 05/07/2010 Completed
P050010 SYNTHES SPINE PRODISC -L TOTAL DISC REPLACEMENT DEVICE Orthopedic 08/14/2006 PRODISC-L Long Term Study 08/14/2006 Completed
P070001 SYNTHES SPINE PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 Long Term Study 08/12/2008 Progress Adequate
Enhanced Surveillance Study 08/12/2008 Completed
P030011
S011
SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 INTERMACS Companion 06/17/2014 Study Pending
Enhanced Surveillance 08/20/2012 Revised/Replaced Study
H100006 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM (DPS) Anesthesiology 09/28/2011 NeuRx DPS 09/28/2011 Progress Inadequate
P020012 SUNEVA MEDICAL, INC. ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER General &
Plastic Surgery
10/27/2006 Study P521-01 10/27/2006 Progress Adequate
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 Long term 05/12/2006 Revised/Replaced Study
Stelkast Surpass Active PAS 04/22/2011 Progress Inadequate
P030016 STAAR SURGICAL CO. VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 Axial Lengths 12/22/2005 Completed
Follow-up Study 12/22/2005 Completed
Adverse Event Study 12/22/2005 Progress Adequate
P040021 ST. JUDE MEDICAL, INC. SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE Cardiovascular 08/05/2005 Biocor & Biocor Supra Valves 08/03/2006 Progress Adequate
P910023
S088
ST. JUDE MEDICAL, INC. EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 03/14/2006 EPIC Notifiers 03/14/2006 Completed
P910023
S154
ST. JUDE MEDICAL, INC. PROMOTE CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 PAS 09/09/2010 Progress Adequate
P950022
S042
ST. JUDE MEDICAL, INC. RIATA ST OPTIM AND RIATA STS OPTIM Cardiovascular 01/13/2009 SJ4 PAS 05/07/2009 Progress Adequate
P100029 ST. JUDE MEDICAL, INC. ST JUDE MEDICAL TRIFECTA VALVE Cardiovascular 04/20/2011 Trifecta Valve PAS 04/20/2011 Progress Adequate
P950022
S085
ST. JUDE MEDICAL, INC. OPTISURE Cardiovascular 02/21/2014 Optisure Lead Post Approval Study Study Pending
Externalization and Abrasion Sub-Study Study Pending
P030054
S173
ST. JUDE MEDICAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Cardiovascular 11/29/2011 QUAD PAS 03/02/2012 Progress Adequate
P100045 ST. JUDE MEDICAL CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Cardiovascular 05/28/2014 Newly Enrolled Champion 05/28/2014 Study Pending
Champion Substudy Protocol Pending
P030054
S067
ST. JUDE MEDICAL ATLAS II + HF CRT-D SYSTEM Cardiovascular 01/13/2009 SJ4 Post Approval Study 05/07/2009 Progress Adequate
P030054
S130
ST. JUDE MEDICAL QUICKFLEX U MODEL 1258T LEAD Cardiovascular 05/10/2010 QuickFlex u Model 1258T LV lead 05/04/2010 Progress Adequate
P030054
S019
ST. JUDE MEDICAL EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.0M SOFTWARE Cardiovascular 03/14/2006 Longterm 03/14/2006 Completed
H060002 SPIRATION, INC. IBV VALVE SYSTEM Anesthesiology 10/24/2008 IBV Valve 11/27/2009 Progress Inadequate
P040028 SPECTRA SCIENCE LUMA CERVICAL IMAGING SYSTEM Obstetrics/
Gynecology
03/16/2006 LUMA 03/16/2006 Terminated
P060038
S017
SORIN GROUP USA INC. MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) Cardiovascular 04/18/2014 NEMO PAS 07/15/2014 Study Pending
P060027 SORIN GROUP CRM USA, INC OVATIO CRT SYSTEM Cardiovascular 05/15/2008 Long Term 10/31/2008 Other
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 US Study 05/09/2006 Progress Inadequate
UK Study 05/09/2006 Completed
P050050 SMALL BONE INNOVATIONS, INC. SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 Long Term Study 05/09/2014 Progress Adequate
Actual Conditions of Use Study 11/23/2010 Progress Adequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 US Post-Approval Study (US-PAS) 05/29/2012 Progress Adequate
Post-Approval Case-Control Studies (PACCS) 01/11/2012 Progress Adequate
Post-Approval PMA Cohorts Study (PACS) 05/29/2012 Progress Adequate
Post-Approval Continued Access Study (PACAS) 05/29/2012 Completed
Focus Group Study 06/07/2012 Completed
H110002 SECOND SIGHT, LLC. ARGUS II RETINAL PROSTHESIS SYSTEM Ophthalmic 02/13/2013 Extended f/u of the Argus II Feasibility Study 02/13/2013 Progress Adequate
New Enrollment Argus II 02/13/2013 Progress Adequate
P100014 SALIX PHARMACEUTICALS, INC. SOLESTA INJECTABLE GEL Gastroenterology/
Urology
05/27/2011 Solesta - Long Term Study 02/26/2014 Progress Adequate
P100020 ROCHE MOLECULAR SYSTEMS, INC. COBAS HPV TEST Microbiology 04/19/2011 MWP-HPV-159 04/19/2011 Progress Adequate
P040024 Q-MED AB RESTYLANE INJECTABLE GEL General &
Plastic Surgery
03/25/2005 Restylane 03/25/2005 Completed
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 Nit-Occlud PDA PAS 08/01/2014 Progress Adequate
P070005 PATHFINDER CELL THERAPY INC. REPEL-CV BIORESORBABLE ADHESION BARRIER Cardiovascular 03/06/2009 REPEL CV 03/06/2009 Other
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 06/06/2007 Completed
P110008 PARADIGM SPINE, LLC COFLEX INTERLAMINAR STABILIZATION DEVICE Orthopedic 10/17/2012 Coflex Long-Term PAS 04/23/2013 Progress Inadequate
Coflex Actual Practice PAS 04/23/2013 Progress Inadequate
P130004 OCULAR THERAPEUTICS, INC. RESURE SEALANT Ophthalmic 01/08/2014 Device Exposure Registry Study Protocol Overdue
Clinical PAS Protocol Overdue
P070009 OBTECH MEDICAL GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X Gastroenterology/
Urology
09/28/2007 Realize PAS 09/09/2008 Progress Adequate
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 PCM Cervical Enhanced Surveillance 04/10/2013 Progress Adequate
PCM Cervical Long Term 02/06/2013 Progress Adequate
P100034 NOVOCURE, LTD. NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 New Enrollment Study for NovoTTF-100A 01/03/2012 Progress Inadequate
P000049
S016
NMT MEDICAL, INC. STARFLEX SEPTAL OCCLUSION SYSTEM Cardiovascular 03/05/2009 Fatigue & Corrosion Testing 03/05/2009 Other
H100002 NEUROVASX CPAX ANEURYSM TREATMENT SYSTEM Neurology 04/01/2011 New Enrollment Study Other
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 Continued F/u - Long Term Treatment (LTT) 04/23/2012 Progress Inadequate
New Enrollment - All Comers 02/07/2014 Study Pending
New Enrollment - Performance & Programming 02/24/2014 Study Pending
Lead Extraction Study 02/18/2014 Progress Adequate
Autopsy Study 02/14/2014 Study Pending
P010047
S010
NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 NeoMend ProGel Pleural Air Leak Sealant 03/19/2012 Progress Adequate
P010047 NEOMEND, INC. PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 01/14/2010 Long Term Safety 11/08/2013 Progress Adequate
P040025 NATUS MEDICAL INCORPORATED OLYMPIC COOL-CAP Neurology 12/20/2006 VON Registry 12/20/2006 Completed
P030042 MICROPORT ORTHOPEDICS INC. CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM Orthopedic 11/03/2009 ConservePlus Longer-Term PAS 07/16/2010 Progress Inadequate
ConservePlus New Enrollment PAS 06/21/2010 Progress Inadequate
P100018 MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 Continued Follow-up of Premarket Cohort 06/27/2011 Progress Adequate
P050052 MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
12/22/2006 Long Term (Nasolabial Folds) 12/22/2006 Completed
Short Term (Fitzpatrick) 12/22/2006 Completed
P050037 MERZ NORTH AMERICA, INC RADIESSE 1.3CC AND 0.3CC General &
Plastic Surgery
12/22/2006 Radiesse 12/22/2006 Completed
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology
11/10/2005 Coaptite 09/29/2008 Progress Adequate
P090016 MERZ NORTH AMERICA, INC BELOTERO BALANCE General &
Plastic Surgery
11/14/2011 Concentration and Molecular Weight 03/08/2013 Progress Adequate
Belotero Balance PAS 05/01/2012 Completed
Chemical/Physical Evaluation 12/07/2012 Progress Adequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 Post-Approval PMA Cohort Study (PACS) 06/14/2013 Progress Adequate
Post-approval Continued Access Study (PACAS) 06/14/2013 Study Pending
MemoryShape Post-Approval Study (MemoryShape PAS) 06/14/2013 Study Pending
Breast Implant Case-Control Studies 06/14/2013 Progress Adequate
Focus Group Study 06/14/2013 Progress Adequate
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Large PAS 11/17/2006 Progress Inadequate
Adjunct Study 11/17/2006 Completed
Core 11/17/2006 Completed
Focus Group 11/17/2006 Completed
Breast Implant Case Control Studies 04/18/2014 Study Pending
Device Failure Study 11/17/2006 Progress Adequate
Informed Decision Process 11/17/2006 Completed
P090012 MELA SCIENCES, INC. MELAFIND General &
Plastic Surgery
11/01/2011 PAS of MelaFind 08/08/2012 Progress Adequate
P090013 MEDTRONIC, INC REVO MRI SURESCAN IPG AND PACING SYSTEM Cardiovascular 02/08/2011 Chronic Lead Performance/Multiple MRI 02/08/2011 Progress Adequate
H080002 MEDTRONIC, INC MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM Cardiovascular 01/25/2010 Long Term PAS 09/02/2010 Progress Adequate
Generalizability Study 04/06/2010 Progress Adequate
P070027 MEDTRONIC VASCULAR THE TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 04/15/2008 Vitality Trial 11/05/2008 Progress Adequate
P070007 MEDTRONIC VASCULAR TALENT THORACIC STENT GRAFT SYSTEM Cardiovascular 06/05/2008 THRIVE Trial 01/04/2011 Progress Adequate
P070012 MEDTRONIC VASCULAR EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM Cardiovascular 10/23/2007 EMERGE 10/23/2007 Terminated
MAVErIC II Long Term Study 10/23/2007 Completed
P070027
S011
MEDTRONIC VASCULAR TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 02/04/2010 Registry 07/16/2014 Progress Adequate
P100021 MEDTRONIC VASCULAR MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 ENGAGE 01/24/2014 Progress Adequate
P100040 MEDTRONIC VASCULAR VALIANT THORACIC STENT GRAFT SYSTEM Cardiovascular 04/01/2011 Captivia Delivery System 09/14/2011 Progress Adequate
P110013 MEDTRONIC VASCULAR RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/17/2012 Resolute Integrity 02/17/2012 Progress Adequate
Continued Follow-up of Premarket and OUS Cohort 02/17/2012 Progress Adequate
P110013
S005
MEDTRONIC VASCULAR RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 Resolute Integrity PAS Newly Enrolled 02/21/2013 Progress Adequate
Continued F/u of Premarket and OUS Cohort 02/22/2013 Progress Adequate
P110040 MEDTRONIC VASCULAR MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM Cardiovascular 09/19/2013 Complete SE SFA Long Term Study 09/19/2013 Study Pending
P100040
S012
MEDTRONIC VASCULAR VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 Surveillance
Valiant Dissection PAS Terminated
P040001 MEDTRONIC SOFAMOR DANEK, INC. X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM Orthopedic 11/21/2005 COAST Study 12/08/2006 Progress Inadequate
LTOS Study 12/08/2006 Completed
P060018 MEDTRONIC SOFAMOR DANEK, INC. PRESTIGE CERVICAL DISC SYSTEM Orthopedic 07/16/2007 Enhanced Surveillance 07/16/2007 Completed
Long-Term Study 07/16/2007 Progress Adequate
P060023 MEDTRONIC SOFAMOR DANEK USA, INC. BRYAN CERVICAL DISC PROSTHESIS Orthopedic 05/12/2009 Long-Term Study 05/12/2009 Progress Adequate
Enhanced Surveillance 05/12/2009 Progress Adequate
P080025 MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM Gastroenterology/
Urology
03/14/2011 FI-PAS 03/14/2011 Completed
P980022
S012
MEDTRONIC MINIMED GUARDIAN RT Clinical Chemistry 08/24/2005 PXX/GS041/A 12/27/2006 Completed
P060033 MEDTRONIC INC. ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 02/01/2008 Registry PROTECT CA 09/16/2008 Progress Adequate
Dual Antiplatelet Therapy EDUCATE 02/01/2008 Progress Adequate
5yr Clinical Outcomes 02/01/2008 Completed
Product Testing 02/01/2008 Completed
P060039 MEDTRONIC INC. ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 Chronic Extraction 02/02/2009 Progress Inadequate
Chronic Performance Study 11/19/2013 Progress Adequate
P010031
S104
MEDTRONIC INC. CONCERTO/INSYNC SENTRY/INSYNC MAXIMO Cardiovascular 08/28/2008 Enhanced Surveillance 08/28/2008 Completed
P980016
S135
MEDTRONIC INC. VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR Cardiovascular 08/28/2008 Enhanced Surveillance 08/28/2008 Completed
P080006 MEDTRONIC INC. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 Elution 04/07/2009 Completed
Chronic Lead Performance 12/05/2013 Progress Inadequate
P980035
S073
MEDTRONIC INC. MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE Cardiovascular 05/13/2008 Longterm Study PAS 05/13/2008 Progress Adequate
P890003
S119
MEDTRONIC INC. CARELINK MONITOR MODEL 2490H Cardiovascular 05/13/2008 Longterm PAS 05/13/2008 Progress Adequate
P080006
S004
MEDTRONIC INC. MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD Cardiovascular 03/31/2011 Attain Ability Straight Model 4396 03/31/2011 Progress Inadequate
P010031
S176
MEDTRONIC INC. MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 Chronic Lead Performance 11/22/2013 Progress Adequate
P980016
S216
MEDTRONIC INC. MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 Chronic Lead Performance 01/09/2012 Progress Adequate
P890003
S179
MEDTRONIC INC. CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 Chronic Lead Performance 01/09/2012 Progress Adequate
P920015
S055
MEDTRONIC INC. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 Chronic Lead Performance 01/09/2012 Progress Adequate
P080006
S002
MEDTRONIC INC. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 Chronic Lead Performance 09/30/2010 Progress Inadequate
P120010 MEDTRONIC INC. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 PAS of TS Feature w/a Sensor-Augmented Pump System 09/26/2013 Progress Inadequate
P980035
S277
MEDTRONIC INC. ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR Cardiovascular 01/15/2013 SureScan Pacing System Progress Adequate
P890003
S252
MEDTRONIC INC. CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER Cardiovascular 01/15/2013 SureScan Pacing System 01/15/2014 Progress Adequate
P010031
S344
MEDTRONIC INC. PROTECTA XT CRT-D, PROTECTA CRT-D, CONSULTA CRT-D, CONCERTO II CRT-D, MAXIMO II CRT-D Cardiovascular 09/25/2013 LIA in Non-MDT Leads Surveillance Update Analysis 09/25/2013 Progress Adequate
P980016
S394
MEDTRONIC INC. PROTECTA XT ICD, PROTECTA ICD, SECURA ICD, VIRTUOSO II ICD, MAXIMO II ICD Cardiovascular 09/25/2013 LIA in Non-MDT Leads Surveillance Update Analysis 09/25/2013 Progress Adequate
P010031
S232
MEDTRONIC INC. CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT Cardiovascular 04/04/2012 REVERSE NCDR ICD Registry Study 06/29/2012 Progress Adequate
REVERSE Product Surveillance Registry 06/29/2012 Progress Inadequate
P100010 MEDTRONIC CRYOCATH LP ARCTIC FRONT CRYOCATHETER SYSTEM Cardiovascular 12/17/2010 Sustained Treatment of Paroxysmal Atrial Fibrillat 12/18/2013 Progress Adequate
P130021
S002
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 Continued f/u of the premarket cohorts (high risk) Study Pending
Surveillance
P130021 MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 Contined f/u of IDE pivotal cohort 01/10/2014 Study Pending
Continued f/u of continued access cohort 01/10/2014 Study Pending
New Enrollment of extreme risk patients Terminated
P060025 MEDTRONIC ATS MEDICAL, INC. ATS 3F AORTIC BIOPROSTHESIS Cardiovascular 10/30/2008 ATS 3f 08/12/2009 Progress Inadequate
P110004 MEDINOL LTD. PRESILLION PLUS COCR CORONARY STENT RX SYSTEM Cardiovascular 04/12/2012 Continued f/u of BLAST Placebo Cohort 01/24/2012 Progress Adequate
Enrollment of New US Cohort 01/24/2012 Progress Inadequate
P040013
S016
LUITPOLD PHARMACEUTICALS, INC. GEM 21S GROWTH FACTOR ENHANCED MATRIX Dental 05/27/2011 GEM21S Growth Factor 12/06/2011 Progress Adequate
P110032 LOMBARD MEDICAL TECHNOLOGIES INC AORFIX FLEXIBLE STENT GRAFT SYSTEM Cardiovascular 02/14/2013 Aorfix Post Approval Study 11/01/2013 Study Pending
P110009 LDR SPINE USA INC. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 Long Term PAS 05/08/2014 Study Pending
Enhanced Surveillance System 05/19/2014 Study Pending
Retrieval Analysis 07/15/2014 Study Pending
P110002 LDR SPINE USA MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 Retrieval Analysis 07/15/2014 Study Pending
Extended f/u of premarket cohort 05/27/2014 Progress Adequate
Enhanced Surveillance System 06/03/2014 Progress Adequate
H120005 KANEKA PHARMA AMERICA LLC KANEKA LIPOSORBER APHERESIS SYSTEM Gastroenterology/
Urology
10/10/2013 New Enrollment PAS for the Liposorber LA-15 System 04/25/2014 Study Pending
P040034 INTEGRA LIFESCIENCES CORPORATION DURASEAL DURAL SEALANT SYSTEM Neurology 04/07/2005 Duraseal 04/07/2005 Completed
P080013 INTEGRA LIFESCIENCES CORPORATION DURASEAL EXACT SPINE SEALANT SYSTEM Neurology 09/04/2009 DuraSeal Exact Spine Sealant System 02/06/2014 Progress Inadequate
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 Extended F/U Premarket Cohort Inspire 4 STAR Trial 04/30/2014 Study Pending
New Enrollment Study 04/30/2014 Study Pending
P040003
S006
INSIGHTEC, INC. EXABLATE 2100 SYSTEM Obstetrics/
Gynecology
12/22/2009 Exablate 2100 Type 1.0 04/19/2010 Completed
P110039 INSIGHTEC EXABLATE General &
Plastic Surgery
10/18/2012 New Enrollment Study 03/15/2013 Progress Adequate
Enhanced Surveillance Registry Study 03/15/2013 Progress Adequate
P010013
S041
HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
02/01/2013 NovaSure PAS 05/30/2014 Progress Adequate
P080014 HOLOGIC, INC. CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT Microbiology 03/12/2009 Cervista HPV HR Assay 03/12/2009 Completed
P080015 HOLOGIC, INC. CERVISTA HPV 16/18 Microbiology 03/12/2009 Cervista HPV HR Assay 03/12/2009 Completed
P070022 HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM Obstetrics/
Gynecology
07/06/2009 EASE TRIAL 07/06/2009 Terminated
P040052 HOLOGIC, INC. MONOPREP PAP TEST Pathology 03/03/2006 CHOICE Study 12/18/2007 Other
SURE Study 10/18/2007 Completed
P100047 HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 Newly Enrolled (HW-PAS-01) 11/20/2012 Progress Adequate
Training Program (HeartWare-PAS-02) 11/20/2012 Progress Adequate
Continued Follow-Up (HW-PAS-03) 02/14/2014 Progress Adequate
P010012
S160
GUIDANT CORP. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 ACUITY Long-Term Registry 06/25/2009 Progress Inadequate
P910073
S077
GUIDANT CORP. ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P830060
S062
GUIDANT CORP. LEAD TUNNELER MODEL 6888 Cardiovascular 11/10/2010 Longitudinal Surveillance Study 01/14/2011 Terminated
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 Extended f/u of premarket cohort 07/16/2014 Progress Inadequate
Enhanced Surveillance 05/08/2014 Progress Adequate
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 Extended F/u of IDE Cohort Study 03/05/2013 Progress Adequate
New Enrollment Study 03/08/2013 Progress Inadequate
Registry Study 03/05/2013 Progress Adequate
P100042 GEN-PROBE INCORPORATED APTIMA HPV ASSAY Microbiology 10/28/2011 APTIMA HPV Assay 10/28/2011 Progress Adequate
P120007 GEN-PROBE INCORPORATED APTIMA HPV 16 18/45 GENOTYPE ASSAY Microbiology 10/12/2012 HPVGTS-US-10-002 10/12/2012 Progress Adequate
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 Prometra Programmable Pump system 05/03/2012 Progress Inadequate
Extended Use Stability Study 05/04/2012 Progress Inadequate
Leachables Study 05/04/2012 Progress Adequate
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 Long Term 07/05/2007 Revised/Replaced Study
Novation PAS 12/09/2010 Progress Adequate
P030004 EV3 NEUROVASCULAR ONYX LIQUID EMBOLIC SYSTEM Neurology 07/21/2005 Long Term Study 07/21/2005 Completed
P060001 EV3 INC PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS Cardiovascular 01/24/2007 CREATE (IDE) 08/02/2007 Completed
CREATE PAS 08/02/2007 Completed
P110023 EV3 INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 Durability II PAS 03/07/2012 Progress Adequate
Cont FU of Premarket Cohort 03/07/2012 Completed
P970021
S014
ETHICON WOMEN'S HEALTH & UROLOGY GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM Obstetrics/
Gynecology
07/06/2007 Long-Term Study 01/29/2008 Completed
P080009 ETHICON ENDO-SURGERY, INC. SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM Anesthesiology 05/03/2013 Open Label Post Market Registry in Clinical Practi 03/29/2013 Other
Open Label PAS of the SEDASYS System User Response 03/29/2013 Other
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 Extended Follow-up of PMA study 08/16/2010 Progress Adequate
New Enrollment 08/16/2010 Progress Inadequate
H080005 ELANA INC. ELANA ARTERIOTOMY SYSTEM Neurology 03/10/2011 Elana Surgical KitHUD 03/10/2011 Progress Inadequate
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 04/28/2006 Completed
P860057
S023
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700TFX, 2800TFX, 3000TFX, AND 6900PTX Cardiovascular 04/07/2005 Carpentier Edwards PAS 04/07/2005 Completed
P860057
S029
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 Long Term 01/24/2014 Progress Adequate
P860057
S042
EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 Clinical Study 11/03/2009 Progress Adequate
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 Continue Follow-Up of Premarket Cohort 01/31/2012 Progress Inadequate
Newly Enrolled Study 11/06/2012 Progress Inadequate
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 Continued F/U of the IDE inoperable pts cohort(B) Protocol Pending
Surveillance
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 Continue F/u of Premarket Cohort 10/19/2012 Progress Adequate
Newly Enrolled Study 09/13/2013 Progress Adequate
P110014 DUNE MEDICAL DEVICES INC DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery
12/27/2012 MarginProbe System US PAS 04/29/2014 Study Pending
P070026
S004
DEPUY, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 Long-Term F/U of IDE COC36 patients 07/02/2013 Progress Inadequate
Short to Mid-Term F/u of New COC36 patients 08/28/2013 Progress Inadequate
COC36 PAS: UK & Australian National Joint Registry 11/21/2013 Progress Adequate
P070026 DEPUY, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 Ceramax PAS 05/19/2014 Progress Inadequate
P090002 DEPUY ORTHOPAEDICS, INC. PINNACLE COMPLETE ACETABULAR HIP SYSTEM Orthopedic 06/13/2011 Pinnacle CoMplete Acetabular Hip System 11/04/2011 Terminated
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 Duraloc Long Term 05/03/2005 Revised/Replaced Study
Kaiser Permanente Joint Registry 04/20/2010 Terminated
National Joint Registry for England and Wales 04/20/2010 Terminated
Australian Orthopedic Assc National Joint Registry 04/20/2010 Terminated
Prospective Post-Approval Study 04/20/2010 Terminated
DePuy Outcomes Tracking System Registry (DOTS) 04/20/2010 Terminated
New England Baptist Hospital Joint Registry 06/12/2012 Terminated
P970003
S050
CYBERONICS, INC. VNS THERAPY SYSTEM Neurology 07/15/2005 Registry Study 07/15/2005 Progress Inadequate
Dosing Study D-21 07/15/2005 Completed
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 New Enrollment 07/03/2007 Progress Inadequate
Long Term Study 07/03/2007 Progress Adequate
P020026
S017
CORDIS CORPORATION RAPTORRAIL RX SDS, 2.25MM CYPHER STENT Cardiovascular 09/18/2009 CYPHER MINI 08/17/2009 Progress Adequate
P030047 CORDIS CORP. CORDIS PRECISE NITINOL STENT SYSTEM Cardiovascular 09/22/2006 Longterm & CASES Studies 09/22/2006 Completed
P120002 CORDIS CORP. SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS Cardiovascular 11/07/2012 STROLL Post Approval Study 11/07/2012 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 06/09/2005 Completed
P020018
S010
COOK, INC. 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT Cardiovascular 09/07/2006 AAA Flex 36mm 09/07/2006 Completed
P100022 COOK MEDICAL INCORPORATED ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 New US Enrollment 02/15/2013 Progress Inadequate
Zilver PTX Stent PAS 03/01/2013 Progress Inadequate
P100028 COOK MEDICAL INCORPORATED FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM Cardiovascular 01/14/2011 REFORM 12/05/2011 Completed
P020018
S040
COOK INCORPORATED ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 Long Term F/U Study 12/12/2012 Progress Adequate
Training Program 04/02/2014 Progress Adequate
P020014
S017
CONCEPTUS, INC. CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
02/24/2012 Essure/post-NovaSure PAS 02/24/2012 Progress Adequate
P020014
S012
CONCEPTUS, INC. CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/15/2007 ESS-305 06/15/2007 Completed
P070013 COLBAR LIFESCIENCE LTD. EVOLENCE COLLAGEN FILLER General &
Plastic Surgery
06/27/2008 EVOLENCE 09/15/2008 Terminated
P890055
S026
CODMAN & SHURTLEFF, INC. CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 Long-Term Surveillance of MedStream 03/15/2011 Other
Leachables Study 03/15/2011 Progress Adequate
Drug Stability Study 03/15/2011 Progress Adequate
P970051
S028
COCHLEAR AMERICAS NUCLEUS 24 COCHLEAR IMPLANT SYSTEM Ear Nose & Throat 03/01/2005 Pediatric Study 03/01/2005 Completed
Adult Study 03/01/2005 Completed
P130016 COCHLEAR AMERICAS NUCLEUS HYBRID L24 IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 Extended f/u study Protocol Pending
New Enrollment Study Protocol Pending
P970029
S014
CARDIOGENESIS CORP. CARDIOGENESIS HOLMIUM TMR SYSTEM Cardiovascular 02/22/2012 PEARL 8.0 New Enrollment Study 01/28/2014 Progress Adequate
P110042 CAMERON HEALTH, INC SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 S-ICD PAS Registry 06/22/2012 Progress Adequate
H090002 BSD MEDICAL CORP. HYPERTHERMIA SYSTEM Obstetrics/
Gynecology
11/18/2011 Enhanced Surveillance Study 11/13/2013 Progress Inadequate
Registry Study 11/13/2013 Progress Adequate
Deep Hyperthermia and Radiation 11/13/2013 Revised/Replaced Study
P040016 BOSTON SCIENTIFIC SCIMED, INC. VERIFLEX (LIBERTE) BARE-METAL CORONARY STEM SYSTEM Cardiovascular 04/12/2005 Longterm Outcomes 04/12/2005 Completed
P010012
S230
BOSTON SCIENTIFIC CORPORATION (BSC) BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 MADIT-CRT ACC NCDR 01/18/2013 Progress Inadequate
MADIT-CRT Registry 09/27/2011 Completed
P060008
S011
BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 07/13/2009 TAXUS Long (S011) 07/23/2010 Completed
P060008
S008
BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 05/21/2009 TAXUS ATLAS Small Vessel 07/23/2009 Completed
P080032 BOSTON SCIENTIFIC CORP. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 AIR2 - Extended Study 07/27/2010 Completed
New Patient Study 09/14/2010 Progress Adequate
P000040
S014
BOSTON SCIENTIFIC CORP. GENESYS HTA SYSTEM Obstetrics/
Gynecology
04/23/2010 Genesys HTA Post Approval Registry 04/23/2012 Completed
P100023 BOSTON SCIENTIFIC CORP. ION PACLITAXEL- ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE SYSTEMS) Cardiovascular 04/22/2011 PERSEUS Workhorse and Small Vessel (SV) Progress Adequate
ION Post Approval Study 12/15/2011 Progress Adequate
P050019 BOSTON SCIENTIFIC CORP. CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS Cardiovascular 10/23/2008 CABANA REGISTRY 10/23/2008 Completed
BEACH STUDY 10/23/2008 Completed
P060006 BOSTON SCIENTIFIC CORP. BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM Cardiovascular 12/11/2008 BSC Express PAS 12/11/2008 Completed
P060008 BOSTON SCIENTIFIC CORP. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 TAXUS Registry 10/10/2008 Progress Inadequate
Dual Antiplatelet Study 01/21/2014 Progress Adequate
Fatigue & Stability Testing 10/10/2008 Progress Adequate
Outcomes TAXUS ATLAS 10/10/2008 Completed
P030025
S028
BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER -THE-WIRE) Cardiovascular 09/24/2008 5 year Clinical Outcomes 09/24/2008 Completed
Fatigue/Matter Testing 09/24/2008 Completed
P030025
S021
BOSTON SCIENTIFIC CORP. TAXUS EXPRESS2 PACLITAXEL CORONARY STENT SYSTEM Cardiovascular 09/24/2008 5 year clinical outcomes 09/24/2008 Completed
Fatigue/Matter Testing 09/24/2008 Completed
P050024 BOSTON SCIENTIFIC CORP. CRYOCOR CRYOABLATION SYSTEM Cardiovascular 08/01/2007 Cryocor Ablation PAS 03/13/2008 Terminated
P110010
S001
BOSTON SCIENTIFIC CORP. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 06/01/2012 PROMUS Element Plus US PAS 08/24/2012 Progress Adequate
Continued F/U of Premarket Cohort 08/23/2012 Progress Adequate
P110010 BOSTON SCIENTIFIC CORP. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 PROMUS Element Plus US Post Approval Study 05/10/2012 Progress Adequate
Continued F/u of Premarket Cohort 05/11/2012 Progress Adequate
P050025 BOSTON SCIENTIFIC ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM Cardiovascular 10/27/2006 CABERNET Registry 10/12/2006 Completed
SONOMA 10/12/2006 Other
P960040
S198
BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study 12/21/2012 Progress Adequate
P010012
S212
BOSTON SCIENTIFIC COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 Relay Thoracic Stent-Graft w Plus Delivery System 12/18/2012 Progress Inadequate
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 12/23/2010 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 (COSMO) 08/10/2006 Completed
TUPOS LV 08/10/2006 Completed
P040036 BIOSENSE WEBSTER, INC. NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Cardiovascular 08/11/2006 NaviStar Study 08/11/2006 Completed
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 CABANA Trial 11/24/2009 Progress Adequate
Atrial Fibrillation Registry 08/12/2009 Progress Adequate
P040013
S009
BIOMIMETIC THERAPEUTICS, INC. GEM 21S (GROWTH ENHANCED MATRIX) Dental 08/10/2007 Working Standard for Biomatrix 08/25/2008 Completed
P050009 BIOMET, INC. C2 A-TAPER ACETABULAR SYSTEM Orthopedic 12/16/2005 Long Term Study 12/16/2005 Progress Inadequate
P020016 BIOMET MICROFIXATION, INC. WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM Dental 09/21/2005 Longterm Followup Study 09/21/2005 Completed
H100004 BERLIN HEART INC. EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE Cardiovascular 12/16/2011 All Comers Registry 07/27/2012 Progress Adequate
P030002
S027
BAUSCH & LOMB, INC. CRYSTALENS TORIC ACCOMODATING POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 New Enrollment Study 06/27/2014 Study Pending
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 LifeStent SOLO 07/11/2014 Progress Inadequate
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 CONTINUUM Long Lesion 07/11/2014 Progress Inadequate
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 CONTINUUM 07/11/2014 Progress Adequate
RESILIENT 02/13/2009 Completed
P060002 BARD PERIPHERAL VASCULAR FLAIR ENDOVASCULAR STENT GRAFT Cardiovascular 07/23/2007 FLAIR Endovascular Grafts 03/13/2008 Completed
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 AtriCure Synergy Ablation System 06/13/2014 Progress Adequate
P050033 ANIKA THERAPEUTICS, INC. HYDRELLE General &
Plastic Surgery
12/20/2006 Elevess CTA Study 04/29/2008 Completed
P000053
S005
AMERICAN MEDICAL SYSTEMS, INC. SPHINCTER 800 URINARY CONTROL SYSTEM Gastroenterology/
Urology
10/13/2006 Registry AMS MC-0611 02/07/2007 Completed
P000032
S028
AMERICAN MEDICAL SYSTEMS, INC. HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM Obstetrics/
Gynecology
03/27/2009 Her Option PAS 03/27/2009 Completed
P000008
S017
ALLERGAN, INC. LAP-BAND Gastroenterology/
Urology
02/16/2011 LBMI-002 08/15/2011 Progress Adequate
BOLD-001 11/17/2011 Progress Inadequate
P040046 ALLERGAN NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 Core Study 02/20/2013 Completed
Continued Access Study (Natrelle 410 CAS) Progress Adequate
Natrelle 410 US-PAS Study Pending
Case Control Studies Progress Adequate
Focus Group Study Completed
P020056 ALLERGAN NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 Core 11/17/2006 Completed
Focus Group 11/17/2006 Completed
Adjunct 11/17/2006 Completed
BIFS (Large PAS) 10/01/2012 Progress Inadequate
Device failure Study 11/17/2006 Progress Adequate
Informed Decision Process 10/17/2006 Completed
P110033 ALLERGAN JUVEDERM VOLUMA XC General &
Plastic Surgery
10/22/2013 VOLUMA-003 Repeat Treatment Study 08/30/2013 Progress Adequate
P930014
S045
ALCON RESEARCH, LTD. ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL Ophthalmic 05/03/2011 New Enrollment PAS 10/25/2011 Progress Adequate
P020024
S037
AGA MEDICAL CORP. AMPLATZER DUCT OCCLUDER II Cardiovascular 08/18/2013 Continued F/u of the Premarket ADO II PAS 11/08/2013 Progress Adequate
P040040 AGA MEDICAL CORP. AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 Post Approval Study 10/01/2010 Progress Inadequate
5 year long term (IDE) 09/07/2007 Terminated
H040006 ABIOMED, INC. ABIOCOR IMPLANTABLE REPLACEMENT HEART Cardiovascular 09/05/2006 Abiocor Artificial Heart 09/05/2006 Other
P040038 ABBOTT VASCULAR INC. XACT CAROTID STENT SYSTEM Cardiovascular 09/06/2005 EXACT Study 10/12/2005 Completed
PROTECT Study 02/05/2007 Completed
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 Device Registry 06/13/2014 Study Pending
MitraClip Analysis Cohort (MAC) 06/12/2014 Study Pending
P070015 ABBOTT VASCULAR INC. XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS Cardiovascular 07/02/2008 Fatigue Testing 07/02/2008 Completed
Longterm IDE Follow up 07/02/2008 Progress Adequate
XIENCE Registry 07/02/2008 Completed
Dual Antiplatelet Therapy 07/02/2008 Progress Adequate
P040012
S034
ABBOTT VASCULAR INC. RX ACCULINK CAROTID STENT SYSTEM Cardiovascular 05/06/2011 CANOPY Trial 05/06/2011 Progress Adequate
P120020 ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) SUPERA PERIPHERAL STENT SYSTEM Cardiovascular 03/28/2014 SUPERB Extended F/U Study Protocol Pending
P070015
S054
ABBOTT VASCULAR XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 05/24/2011 SPIRIT Small Vessel (SV) Registry 05/24/2011 Completed
P110019 ABBOTT VASCULAR XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 11/01/2011 XIENCE PRIME and XIENCE PRIME LL Everolimus Elut 10/27/2011 Completed
P110001 ABBOTT VASCULAR RX HERCULINK ELITE RENAL STENT SYSTEM Cardiovascular 07/20/2011 HERCULES PAS 06/26/2012 Completed
P980040
S039
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 New Enrollment of Post Approval Study 06/12/2014 Study Pending

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