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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: 368 records  
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Current Protocol Accepted
Study Status
P150024 ASPIRE BARIATRICS INC AspireAssist Gastroenterology/
Urology
06/14/2016 OSB Lead-AspireAssist Post-Approval Study Study Pending
ODE Lead-PATHWAY Clinical Trial PAS Study Pending
P070014
S037
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEM Cardiovascular 05/31/2016 Popliteal Indication Post-Approval Surv Project Protocol Pending
P050023
S094
BIOTRONIK, INC. IPERIA 7 HF-T (DR-1) & (DF-4); INVENTRA 7 HF-T (DF-1) & (DF-4) Cardiovascular 05/02/2016 OSB Lead-ProMRI ICD/CRT-D System Home Monitorin Protocol Pending
P980016
S555
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT EVERA MRI XT DR/VR SURESCAN,EVERA MRI S DR/VR SURESCAN ICDS AND PROGRAMMER SOFTWARE Cardiovascular 04/28/2016 OSB Lead-Post-Approval Study Study Pending
P150012 BOSTONSCIENTIFIC IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD Cardiovascular 04/25/2016 ODE Lead-INGEVITY and SAMURAI Study Pending
P130001 EPIGENOMICS AG Epi proColon Pathology 04/12/2016 OSB Lead-Epi proColon PAS Protocol Pending
P140003
S004
ABIOMED, INC. IMPELLA VENTRICULAR SUPPORT SYSTEMS Cardiovascular 04/07/2016 OSB Lead-Impella AMI CS PAS Protocol Pending
P140003
S005
ABIOMED, INC. IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM Cardiovascular 04/07/2016 OSB Lead-Impella PCCS PAS Protocol Pending
P150033 MEDTRONIC Inc. MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM Cardiovascular 04/06/2016 ODE Lead-Micra Rate Resp Conf Study Study Pending
OSB Lead-Micra Transcatheter Pacing System PAS Study Pending
P150026 CARDIOFOCUS, INC. HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM Cardiovascular 04/01/2016 OSB Lead-PAS of HeartLight Endoscopic Ablation Sys Study Pending
P150028 NUMED, INC. CHEATHAM PLATINUM STENT SYSTEM Cardiovascular 03/25/2016 ODE Lead-Continued f/u of Premarket Cohorts Study Pending
ODE Lead-Cont f/u of premarket cohorts w/stent fra Study Pending
P020004
S123
W.L. GORE & ASSOCIATES,INC GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS Cardiovascular 02/29/2016 ODE Lead-Post-Approval Study Study Pending
P130009
S037
EDWARDS LIFESCIENCES, LLC. SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 02/29/2016 ODE Lead-COMPASSION Cohort Study Pending
OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS Protocol Pending
P010012
S398
Boston Scientific Corp. ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE Cardiovascular 02/22/2016 ODE Lead-ACUITY X4 Post Approval Study Study Pending
P150004 Spinal Modulation, Inc Axium Neurostimulator System Neurology 02/11/2016 F/U of the Axium Neurostimulator System (FANS) 05/26/2016 Study Pending
P050023
S087
BIOTRONIK, INC. IFORIA 7 DR-T (DF-1 & DF4), IPERIA 7 DR-T (DF-1 & DF-4), INVENTRA 7 DR-T (DF-1 & DF-4) Cardiovascular 12/21/2015 OSB Lead-ProMRI ICD Post-Approval Study Study Pending
H130006 TORAX MEDICAL, INC. FENIX CONTINENCE RESTORATION SYSTEM Gastroenterology/
Urology
12/18/2015 ODE Lead-HDE Post-Approval Study Study Pending
P010030
S056
ZOLL MANUFACTURING CORPORATION LIFEVEST WEARABLE DEFIBRILLATOR Cardiovascular 12/17/2015 OSB Lead-PMA Post-Approval Study Study Pending
P130018 UROMEDICA INC PROACT ADJUSTABLE INCONTINENCE THERAPY FOR MEN Gastroenterology/
Urology
11/24/2015 OSB Lead-ProAct Post-Approval Study Protocol Pending
P130021
S016
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE AND COREVALVE EVOLUT R SYSTEMS Cardiovascular 11/10/2015 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Comprehensive/Linked-Registry Based Surv Study Pending
P140019 CERAPEDICS, LLC I-FACTOR PEPTIDE ENHANCED BONE GRAFT Orthopedic 11/03/2015 ODE Lead-Post-Approval Study Progress Adequate
P130009
S034
EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/09/2015 ODE Lead-Continued f/u of the premarket cohort Study Pending
OSB Lead-Comprehensive Linked Registry-Based Surv Progress Adequate
P040003
S016
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
10/05/2015 ODE Lead-Study to Evaluate Safety of ExAblate Progress Adequate
P150003 BOSTON SCIENTIFIC CORPORATION SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 10/02/2015 ODE Lead-EVOLVE Short DAPT Stu;dy Study Pending
P140016 COOK MEDICAL INCORPORATED ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT Cardiovascular 09/15/2015 ODE Lead-Post-Approval Study Study Pending
P890003
S329
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK MONITOR AND EXPRESS MONITOR, CARDIOSIGHT READER; CARELINK EXPRESS Cardiovascular 09/11/2015 OSB Lead-Evera MRI System PAS Study Pending
P100006 BIOMIMETIC THERAPEUTICS,LLC AUGMENT BONE GRAFT Orthopedic 09/01/2015 ODE Lead-Extended f/u of Premarket Cohort 03/18/2016 Study Pending
OSB Lead-2-year New Enrollment Study Protocol Overdue
P040003
S015
INSIGHTEC, LTD EXABLATE Obstetrics/
Gynecology
08/31/2015 OSB Lead-Post ExAblate Pregnancy Outcomes Registry Progress Adequate
P140008 APOLLO ENDOSURGERY INC ORBERA INTRAGASTRIC BALLOON Gastroenterology/
Urology
08/05/2015 OSB Lead-ORBERA PAS (OPAS-001) 02/26/2016 Progress Adequate
P980040
S058
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TENCNIS TORIC 1-PIECE INTRAOCULAR LENS (IOL), TECNIS TORIC 1-PIECE INTRAOCU Ophthalmic 07/31/2015 OSB Lead-ECR IOL PAS Progress Adequate
P140012 RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL BALLOON SYSTEM Gastroenterology/
Urology
07/28/2015 OSB Lead-REDUCE PAS 01/14/2016 Study Pending
P140013 MINERVA SURGICAL MINERVA ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
07/27/2015 ODE Lead-Minerva Single-Arm Study Study Pending
ODE Lead-Minerva Pivotal Study 07/25/2015 Progress Adequate
P140028 BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM Cardiovascular 07/21/2015 ODE Lead-SuperNOVA Continued f/u study Progress Adequate
P020014
S041
BAYER PHARMA AG ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/29/2015 ODE Lead-Post Approval Study 04/28/2016 Study Pending
P140031 EDWARDS LIFESCIENCES, LLC. SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/17/2015 ODE Lead-Continued f/u of premarket cohort Study Pending
OSB Lead-Comprehensive/Linked-Registry Study Pending
P120024 AESCULAP IMPLANT SYSTEMS, LLC ACTIVL ARTIFICIAL DISC Orthopedic 06/11/2015 ODE Lead-Post-Approval Clinical Study Progress Adequate
OSB Lead-Enhanced Safety Surveillance Study 12/17/2015 Progress Adequate
P050052
S049
MERZ NORTH AMERICA, INC RADIESSE INJECTABLE IMPLANT General &
Plastic Surgery
06/04/2015 OSB Lead-Radiesse Radiological Evaluation Study 01/20/2016 Study Pending
OSB Lead-Radiesse New Enrollment Study Study Pending
P140002 TERUMO MEDICAL CORPORATION MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM Cardiovascular 05/22/2015 ODE Lead-OSPREY Extended f/u study Progress Adequate
P140004 VERTIFLEX (R), INCORPORATED SUPERION INTERSPINOUS SPACER Orthopedic 05/20/2015 ODE Lead-SPACER Study Pending
OSB Lead-Superion New Enrollment Study Study Pending
P140026 SILK ROAD MEDICAL, INC ENROUTE TRANSCAROTID STENT SYSTEM Cardiovascular 05/18/2015 OSB Lead-ROADSTER 2 Registry Progress Adequate
P120023 ACUFOCUS, INC. KAMRA INLAY Ophthalmic 04/17/2015 ODE Lead PAS-Continuation Study Progress Adequate
OSB Lead-New Enrollment Study 05/12/2016 Study Pending
P000037
S030
On-X Life Technologies, Inc. ON-X PROSTHETIC HEART VALVE Cardiovascular 04/01/2015 OSB Lead-Newly Enrolled On-X PAS 01/06/2016 Progress Adequate
P130021
S010
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 03/30/2015 ODE Lead-Continued f/u of the premarket cohort Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Progress Adequate
P140003 ABIOMED, INC. IMPELLA Cardiovascular 03/23/2015 OSB Lead-New Enrollment Study Progress Adequate
P130013 Boston Scientific Corp. WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY Cardiovascular 03/13/2015 ODE Lead-Continued f/u of IDE Cohorts Progress Adequate
OSB Lead-WATCHMAN New Enrollment (NESTed-PAS) Protocol Overdue
OSB Lead-WATCHMAN Comprehensive/Linked-Registry Study Pending
H130001 KANEKA PHARMA AMERICA LLC KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMN Gastroenterology/
Urology
03/05/2015 OSB Lead-New Enrollment Study 08/24/2015 Progress Adequate
P950039
S026
HOLOGIC, INC. THINPREP-5000 Pathology 03/02/2015 OIR Lead-Post-Approval Study Progress Adequate
P140017 MEDTRONIC Inc. MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) Cardiovascular 01/27/2015 OSB Lead-Long Term PAS 01/27/2015 Progress Adequate
OSB Lead-New Enrollment Study 01/27/2015 Progress Adequate
H140001 ABIOMED, INC. IMPELLA RP SYSTEM Cardiovascular 01/23/2015 OSB Lead-Impella RP Prospective Study 01/23/2015 Progress Adequate
OSB Lead-Impella RP Pediatric Study 01/23/2015 Progress Adequate
P130019 ENTEROMEDICS INC. MAESTRO RECHARGEABLE SYSTEM Gastroenterology/
Urology
01/14/2015 ODE Lead-Extended F/u of Premarket Cohort 06/02/2015 Progress Adequate
OSB Lead-New Enrollment Study Progress Inadequate
P140010 MEDTRONIC Inc. IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER Cardiovascular 12/30/2014 OSB Lead-IN.PACT SFA Extended f/u study 06/19/2015 Progress Adequate
OSB Lead-Cont f/u of Sub in SFA Global Clin Prog 06/19/2015 Progress Adequate
P080006
S073
MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4398 AND 4598 LEFT VENTRICULAR LEADS Cardiovascular 12/10/2014 OSB Lead-Post-Approval Study Registry 12/10/2014 Progress Adequate
P120011 IDEALIMPLANT IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT General &
Plastic Surgery
11/14/2014 OSB Lead-Post-Approval PMA Cohort Study (PACS) 11/14/2014 Study Pending
P130026 St. Jude Medical TACTICATH QUARTZ SET Cardiovascular 10/24/2014 OSB Lead-TactiCath Quartz PAS 08/20/2014 Progress Adequate
P130024 LUTONIX LUTONIX DRUG COATED BALLOON PTA CATETER Cardiovascular 10/09/2014 OSB Lead-PAS 1 (Extended Follow-up Study) 10/09/2014 Progress Adequate
OSB Lead-PAS 2 (New Enroll. of Female Pat. Study) 01/29/2016 Progress Adequate
P070015
S122
ABBOTT VASCULAR INC. XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 OSB Lead-Extended followup of the EXPERT CTO Study 10/03/2014 Progress Adequate
P110019
S066
ABBOTT VASCULAR XIENCE PRIME EVERLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE X PEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 10/03/2014 OSB Lead-Extended Followup of the EXPERT CTO Study 10/03/2014 Progress Adequate
P040037
S060
W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE Cardiovascular 09/19/2014 OSB Lead-RELINE Extended F/U Study 09/19/2014 Completed
OSB Lead-New Enrollment Study 04/03/2015 Progress Adequate
H120003 XVIVO PERFUSION XPS WITH STEEN SOLUTION PERFUSATE Gastroenterology/
Urology
08/12/2014 OSB Lead-Long-Term Study 04/10/2015 Progress Adequate
P130017 Exact Sciences Corporation COLOGUARD Pathology 08/11/2014 OSB Lead-Cologuard PAS 09/25/2015 Progress Adequate
P080006
S068
MEDTRONIC Inc. ATTAIN PERFORMA MODEL 4298 LEFT VENTRICULAR LEAD Cardiovascular 08/01/2014 OSB Lead-Post-Approval Study Registry 08/01/2014 Progress Adequate
P090029 Medtronic Sofamor Danek USA, Inc. PRESTIGE LP CERVICAL DISC Orthopedic 07/24/2014 OSB Lead-Extended Follow-Up 07/24/2014 Progress Adequate
OSB Lead-Enhanced Surveillance Study 04/06/2015 Progress Adequate
OSB Lead-Device Failure 03/11/2016 Study Pending
P050023
S076
BIOTRONIK, INC. ILESTO/IFORIA 5/7 VRT/DRT ICD'S, ILESTO/IFORIA 5/7 HF-T CRT-D Cardiovascular 07/03/2014 OSB Lead-Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P980023
S057
BIOTRONIK, INC. PROTEGO FAMILY OF ICD LEADS Cardiovascular 07/03/2014 OSB Lead-Protego DF4 Post Approval Registry 07/03/2014 Progress Adequate
P130009 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 06/16/2014 OSB Lead-Cont F/U of the IDE inop pts cohort(B) 09/12/2014 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Based Surv 06/16/2014 Progress Adequate
P130021
S002
MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 06/12/2014 ODE Lead-Continued f/u of the premarket cohorts 06/12/2014 Progress Adequate
OSB Lead-Comprehensive/Linked-Registry Based Surv 06/12/2014 Progress Adequate
P100045 St. Jude Medical CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM Cardiovascular 05/28/2014 OSB Lead-Newly Enrolled Champion 05/28/2014 Progress Adequate
OSB Lead-Champion Substudy 08/29/2014 Progress Adequate
P130008 INSPIRE MEDICAL SYSTEMS INSPIRE II UPPER AIRWAY STIMULATOR Anesthesiology 04/30/2014 OSB Lead-Ext FU Premkt Cohort Inspire 4 STAR Trial 04/30/2014 Progress Adequate
OSB Lead-New Enrollment Study 06/01/2016 Progress Inadequate
P060038
S017
LivaNova Canada Corp. MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL Cardiovascular 04/18/2014 OSB Lead-NEMO PAS 11/25/2014 Progress Adequate
P120020 ABBOTT VASCULAR (IDEF TECHNOLOGIES INC) SUPERA PERIPHERAL STENT SYSTEM Cardiovascular 03/28/2014 SUPERB Extended F/U Study 10/20/2014 Completed
P130016 Cochlear Americas NUCLEUS HYBRID L24 IMPLANT SYSTEM Ear Nose & Throat 03/20/2014 OSB Lead-Extended f/u study 09/11/2014 Progress Adequate
OSB Lead-New Enrollment Study 04/08/2015 Progress Inadequate
P950022
S085
St. Jude Medical, Inc. OPTISURE Cardiovascular 02/21/2014 OSB Lead-OptiSure Lead Post Approval Study 02/21/2014 Progress Adequate
OSB Lead-Externalization and Abrasion Sub-Study 02/21/2014 Study Pending
P100040
S012
Medtronic Vascular VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM Cardiovascular 01/22/2014 OSB Lead-Valiant Dissection PAS Terminated
OSB Lead-Comprehensive/Linked-Registry Based Surv. Progress Adequate
P130021 MEDTRONIC COREVALVE LLC MEDTRONIC COREVALVE SYSTEM Cardiovascular 01/17/2014 ODE Lead-Contined f/u of IDE pivotal cohort 02/17/2014 Revised/Replaced Study
ODE Lead-Continued f/u of continued access cohort 02/17/2014 Revised/Replaced Study
OSB Lead-New Enrollment of extreme risk patients Terminated
P130004 OCULAR THERAPEUTICS, INC. RESURE SEALANT Ophthalmic 01/08/2014 OSB Lead-Device Exposure Registry Study Protocol Overdue
OSB Lead-Clinical PAS 10/02/2014 Progress Adequate
P110004
S001
MEDINOL LTD. NIRXCELL COCR CORONARY STENT ON RX SYSTEM Cardiovascular 12/19/2013 OSB Lead-NIRTRAKS 06/24/2016 Progress Adequate
P100026 NEUROPACE INC NEUROPACE RNS SYSTEM Neurology 11/14/2013 OSB Lead-Continued F/u -Long Term Treatment (LTT) 09/05/2014 Progress Adequate
OSB Lead-New Enrollment - All Comers 06/30/2015 Progress Inadequate
OSB Lead-New Enrollment -Performance & Programming 06/30/2015 Progress Adequate
OSB Lead-Lead Extraction Study 02/18/2014 Progress Adequate
OSB Lead-Autopsy Study 02/14/2014 Progress Adequate
P100009 ABBOTT VASCULAR INC. MITRACLIP DELIVERY SYSTEM Cardiovascular 10/24/2013 OSB Lead-Comprehensive/Linked-Registry Based Surv 06/13/2014 Progress Adequate
OSB Lead-New EnrollMitraClip Analysis Cohort (MAC) 04/05/2016 Progress Adequate
P110033 Allergan JUVEDERM VOLUMA XC General &
Plastic Surgery
10/22/2013 OSB Lead-VOLUMA-003 Repeat Treatment Study 10/22/2013 Completed
P040037
S050
W.L. GORE & ASSOCIATES,INC GORE VIABAHN ENDOPROSTHESIS, GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE Cardiovascular 10/18/2013 OSB Lead-Extended F/u 25cm Viabahn Endoprosthesis 10/18/2013 Progress Adequate
H120005 KANEKA PHARMA AMERICA LLC LIPOSORBER LA-15 SYSTEM Gastroenterology/
Urology
10/10/2013 OSB Lead-New Enroll. PAS for Liposorber LA-15 Sys 02/19/2016 Progress Adequate
P120010 MEDTRONIC Inc. MINIMED 530G SYSTEM Clinical Chemistry 09/26/2013 OSB Lead-PAS of TS Feat. w Sensor-Augment Pump Sys 09/18/2015 Progress Inadequate
P010031
S344
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 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 Completed
P980016
S394
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 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 Completed
P110040 Medtronic Vascular MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM Cardiovascular 09/19/2013 Complete SE SFA Long Term Study 09/19/2013 Completed
P040043
S051
W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 09/10/2013 OSB Lead-TAG Post-Approval Study Terminated
OSB Lead-Comprehensive/Linked-Registry Based Surv Progress Adequate
P110009 LDR SPINE USA INC. MOBI-C CERVICAL DISC PROSTHESIS (TWO-LEVEL INDICATION) Orthopedic 08/23/2013 OSB Lead-Long Term PAS 05/08/2014 Progress Adequate
OSB Lead-Enhanced Surveillance System 05/19/2014 Progress Adequate
OSB Lead-Retrieval Analysis 07/15/2014 Progress Adequate
P020024
S037
AGA MEDICAL CORP. AMPLATZER DUCT OCCLUDER II Cardiovascular 08/18/2013 OSB Lead-Continued F/u of the Premarket ADO II PAS 11/08/2013 Progress Adequate
P120009 PFM MEDICAL, INC NIT-OCCLUD PDA Cardiovascular 08/16/2013 OSB Lead-Nit-Occlud PDA PAS 08/01/2014 Progress Adequate
P110002 LDR Spine USA MOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION) Orthopedic 08/07/2013 OSB Lead-Extended f/u of premarket cohort 05/27/2014 Progress Adequate
OSB Lead-Enhanced Surveillance System 06/03/2014 Progress Adequate
OSB Lead-Retrieval Analysis 07/15/2014 Progress Adequate
P060028 MENTOR WORLDWIDE LLC MENTOR MEMORYSHAPE BREAST IMPLANTS General &
Plastic Surgery
06/14/2013 OSB Lead-Post-Approval PMA Cohort Study (PACS) 06/14/2013 Completed
OSB Lead-Post-approval Cont Access Study (PACAS) 06/14/2013 Completed
OSB Lead-MemoryGel and Shape Combined Cohort 02/12/2016 Study Pending
OSB Lead-Breast Implant Case-Control Studies 06/14/2013 Terminated
OSB Lead-Focus Group Study 06/14/2013 Completed
P030002
S027
Bausch & Lomb, Inc. TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS Ophthalmic 05/20/2013 OSB Lead-New Enrollment Study 02/09/2016 Progress Adequate
P080009 ETHICON ENDO-SURGERY, INC. SEDASYS COMPUTER-ASSISTED PERSONALIZED SEDATION SYSTEM Anesthesiology 05/03/2013 OSB Lead-Open Label PAS of SEDASYS Syst User Resp 03/23/2015 Progress Adequate
Open Label Post Market Registry in Clinical Practi 03/25/2015 Progress Adequate
P980040
S039
ABBOTT MEDICAL OPTICS INC TECNIS TORIC 1-PEICE INTRAOCULAR LENS Ophthalmic 04/15/2013 OSB Lead-New Enrollment of Post Approval Study 08/25/2015 Progress Adequate
P070026
S004
DEPUY ORTHOPAEDICS, INC. DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM Orthopedic 04/02/2013 OSB Lead-Long-Term F/U of IDE COC36 patients 03/10/2015 Progress Adequate
OSB Lead-Short-Mid-Term F/u of New COC36 patients 03/12/2015 Progress Inadequate
OSB Lead-COC36 PAS: UK & Australian Natl Joint Reg 11/21/2013 Progress Adequate
P110013
S005
Medtronic Vascular RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/22/2013 OSB Lead-Resolute Integrity PAS Newly Enrolled 10/16/2014 Progress Adequate
OSB Lead-Continued F/u of Premarket and OUS Cohort 02/22/2013 Progress Adequate
P040046 Allergan NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
02/20/2013 OSB Lead-Core Study 02/20/2013 Completed
OSB Lead-Continued Access Study (Natrelle 410 CAS) Completed
OSB Lead-Natrelle and 410 Combined Cohort 08/03/2015 Study Pending
OSB Lead-Case Control Studies Terminated
OSB Lead-Focus Group Study Completed
P110032 LOMBARD MEDICAL TECHNOLOGIES INC AORFIX FLEXIBLE STENT GRAFT SYSTEM Cardiovascular 02/14/2013 OSB Lead-Aorfix Post Approval Study 11/01/2013 Terminated
OSB Lead-Comprehensive/Linked-Registry Based Surv Progress Adequate
H110002 SECOND SIGHT, LLC. ARGUS II RETINAL PROSTHESIS SYSTEM Ophthalmic 02/13/2013 OSB Lead-Ext f/u of the Argus II Feasibility Study 02/13/2013 Progress Adequate
OSB Lead-New Enrollment Argus II 09/18/2015 Progress Inadequate
P010013
S041
HOLOGIC, INC. NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM Obstetrics/
Gynecology
02/01/2013 OSB Lead-NovaSure PAS 06/15/2015 Progress Inadequate
P980035
S277
MEDTRONIC Inc. ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR Cardiovascular 01/15/2013 OSB Lead-SureScan Pacing System 12/19/2012 Progress Adequate
P890003
S252
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER Cardiovascular 01/15/2013 OSB Lead-SureScan Pacing System 01/15/2014 Progress Adequate
P110014 DUNE MEDICAL DEVICES INC DUNE MEDICAL DEVICES MARGINPROBE SYSTEM General &
Plastic Surgery
12/27/2012 OSB Lead-MarginProbe System US PAS 04/29/2014 Progress Inadequate
P100047 HeartWare, Inc. HEARTWARE VENTRICULAR ASSIST SYSTEM Cardiovascular 11/20/2012 OSB Lead-Newly Enrolled (HW-PAS-01) 01/15/2016 Progress Adequate
OSB Lead-Training Program (HeartWare-PAS-02) 09/25/2015 Progress Adequate
OSB Lead-Continued Follow-Up (HW-PAS-03) 02/14/2014 Progress Adequate
P100022 COOK MEDICAL INCORPORATED ZILVER PTX DRUG-ELUTING PERIPHERAL STENT Cardiovascular 11/14/2012 OSB Lead-New US Enrollment 02/15/2013 Progress Adequate
OSB Lead-Zilver PTX Stent PAS 01/13/2015 Progress Inadequate
P120002 CORDIS CORP. SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS Cardiovascular 11/07/2012 STROLL Post Approval Study 11/07/2012 Completed
P100012 NUVASIVE, INC. NUVASIVE PCM CERVICAL DISC SYSTEM Orthopedic 10/26/2012 OSB Lead-PCM Cervical Enhanced Surveillance 08/25/2015 Progress Adequate
OSB Lead-PCM Cervical Long Term 02/06/2013 Progress Adequate
P110021 EDWARDS LIFESCIENCES LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 10/19/2012 OSB Lead-Continue F/u of Premarket Cohort 10/19/2012 Completed
OSB Lead-Newly Enrolled Study 09/13/2013 Progress Adequate
P110039 InSightec EXABLATE General &
Plastic Surgery
10/18/2012 OSB Lead-New Enrollment Study 03/15/2013 Progress Adequate
OSB Lead-Enhanced Surveillance Registry Study 03/15/2013 Progress Adequate
P110008 PARADIGM SPINE, LLC COFLEX® INTERLAMINAR TECHNOLOGY Orthopedic 10/17/2012 OSB Lead-Coflex Long-Term PAS 04/23/2013 Progress Adequate
OSB Lead-Coflex Actual Practice PAS 04/23/2013 Revised/Replaced Study
OSB Lead-Coflex Actual Practice PAS USA Progress Adequate
P120007 GEN-PROBE INCORPORATED APTIMA HPV 16 18/45 GENOTYPE ASSAY Microbiology 10/12/2012 HPVGTS-US-10-002 10/12/2012 Completed
P120006 TRIVASCULAR INC OVATION ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 10/05/2012 OSB Lead-Long Term Follow-up Study 06/21/2013 Progress Adequate
OSB Lead-Training Program 08/28/2013 Progress Adequate
P110042 BOSTON SCIENTIFIC CORPORATION SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM Cardiovascular 09/28/2012 OSB Lead-S-ICD PAS Registry 09/28/2012 Progress Inadequate
P100003 GLOBUS MEDICAL INC. SECURE-C ARTIFICIAL CERVICAL DISC Orthopedic 09/28/2012 OSB Lead-Extended f/u of premarket cohort 07/16/2014 Progress Adequate
OSB Lead-Enhanced Surveillance 05/08/2014 Progress Adequate
P110038 BOLTON MEDICAL, INC. RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM Cardiovascular 09/21/2012 OSB Lead-Relay Thoracic Stent-Graft w Plus Del Sys 03/06/2015 Progress Adequate
P080030 GLAUKOS, CORPORATION GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L Ophthalmic 06/25/2012 OSB Lead-Extended F/u of IDE Cohort Study 03/05/2013 Completed
OSB Lead-New Enrollment Study 05/13/2016 Progress Inadequate
OSB Lead-Registry Study 07/21/2015 Revised/Replaced Study
P110010
S001
Boston Scientific Corp. PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 06/01/2012 OSB Lead-Continued F/U of Premarket Cohort 08/23/2012 Progress Adequate
OSB Lead-PROMUS Element Plus US PAS 08/24/2012 Progress Adequate
P030011
S011
SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM Cardiovascular 05/16/2012 OSB Lead-Enhanced Surveillance 08/20/2012 Revised/Replaced Study
OSB Lead-INTERMACS Companion 11/27/2015 Progress Adequate
P110004 MEDINOL LTD. PRESILLION PLUS COCR CORONARY STENT RX SYSTEM Cardiovascular 04/12/2012 OSB Lead-Continued f/u of BLAST Placebo Cohort 04/12/2012 Completed
OSB Lead-Enrollment of New US Cohort 04/12/2012 Other
P020018
S040
COOK, INC. ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT Cardiovascular 04/04/2012 OSB Lead-Long Term F/U Study 12/12/2012 Progress Adequate
OSB Lead-Training Program 04/02/2014 Completed
P010031
S232
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT Cardiovascular 04/04/2012 OSB Lead-REVERSE NCDR ICD Registry Study 06/29/2012 Progress Adequate
OSB Lead-REVERSE Product Surveillance Registry 09/17/2012 Progress Inadequate
P100049 TORAX MEDICAL LINX REFLUX MANAGEMENT SYSTEM Gastroenterology/
Urology
03/22/2012 OSB Lead-Extended f/u of premarket cohort 06/22/2012 Completed
OSB Lead-Enrollment Study 06/22/2012 Progress Adequate
P070004 SIENTRA, INC SIENTRA SILICONE GEL BREAST IMPLANTS General &
Plastic Surgery
03/09/2012 OSB Lead-Post-Approval PMA Cohorts Study (PACS) 05/29/2012 Progress Adequate
OSB Lead-Post-Approval Cont Access Study (PACAS) 05/29/2012 Completed
OSB Lead-US Post-Approval Study (US-PAS) 05/29/2012 Progress Adequate
OSB Lead-Post-Approval Case-Control Studies(PACCS) 03/09/2012 Terminated
OSB Lead-Focus Group Study 06/07/2012 Completed
P110023 MEDTRONIC VASCULAR INC EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) Cardiovascular 03/07/2012 OSB Lead-Durability II PAS 09/03/2014 Progress Adequate
OSB Lead-Cont FU of Premarket Cohort 03/07/2012 Completed
P020014
S017
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
02/24/2012 OSB Lead-Essure/post-NovaSure PAS 05/12/2016 Progress Adequate
P970029
S014
CRYOLIFE, INC. CARDIOGENESIS HOLMIUM TMR SYSTEM Cardiovascular 02/22/2012 OSB Lead-PEARL 8.0 New Enrollment Study 01/28/2014 Other
P110013 Medtronic Vascular RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM Cardiovascular 02/17/2012 OSB Lead-Resolute Integrity 02/17/2012 Completed
OSB Lead-Cont Followup of Premarket and OUS Cohort 02/17/2012 Completed
P080012 FLOWONIX MEDICAL, INC. PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM General Hospital 02/07/2012 OSB Lead-Prometra Programmable Pump system 12/28/2015 Progress Adequate
OSB Lead-Extended Use Stability Study 05/04/2012 Progress Adequate
OSB Lead-Leachables Study 05/04/2012 Progress Adequate
P010031
S176
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P980016
S216
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT MEDTRONIC SECURA DR D204DRM, MAXIMO II D264DRM, IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P890003
S179
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK HOME MONITOR MODEL 2490C, CARDIOSIGHT READER MODEL 2020A, CAELINK NETWORK DEVICE Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P920015
S055
MEDTRONIC Inc. MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M Cardiovascular 01/09/2012 OSB Lead-Chronic Lead Performance 11/22/2013 Progress Adequate
P010047
S010
NEOMEND, INC. NEOMEND PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 12/21/2011 OSB Lead-NeoMend ProGel Pleural Air Leak Sealant 03/16/2015 Progress Adequate
H100004 Berlin Heart Inc. EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE Cardiovascular 12/16/2011 OSB Lead-All Comers Registry 07/27/2012 Progress Adequate
P100046 ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM Cardiovascular 12/14/2011 OSB Lead-AtriCure Synergy Ablation System 06/13/2014 Progress Adequate
P030054
S173
St. Jude Medical CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) Cardiovascular 11/29/2011 OSB Lead-QUAD PAS 03/02/2012 Progress Adequate
P110010 Boston Scientific Corp. PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM Cardiovascular 11/22/2011 OSB Lead-PROMUS Element Plus US PAS 05/10/2012 Progress Adequate
OSB Lead-Continued F/u of Premarket Cohort 05/11/2012 Completed
H090002 PYREXAR MEDICAL INC BSD-2000 HYPERTHERMIA SYSTEM Obstetrics/
Gynecology
11/18/2011 OSB Lead-Deep Hyperthermia and Radiation 11/13/2013 Revised/Replaced Study
OSB Lead-Enhanced Surveillance Study 11/13/2013 Progress Inadequate
OSB Lead-Registry Study 11/13/2013 Progress Inadequate
P090016 MERZ NORTH AMERICA, INC BELOTERO BALANCE General &
Plastic Surgery
11/14/2011 Concentration and Molecular Weight 03/08/2013 Completed
Chemical/Physical Evaluation 12/07/2012 Completed
Belotero Balance PAS 05/01/2012 Completed
P100041 EDWARDS LIFESCIENCES, LLC. EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES Cardiovascular 11/02/2011 OSB Lead-Continue Follow-Up of Premarket Cohort 01/31/2012 Completed
OSB Lead-Newly Enrolled Study 08/28/2014 Progress Adequate
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
P090012 STRATA SKIN SCIENCES, INC. MELAFIND General &
Plastic Surgery
11/01/2011 OSB Lead-PAS of MelaFind 10/22/2014 Progress Adequate
P100042 GEN-PROBE INCORPORATED APTIMA HPV ASSAY Microbiology 10/28/2011 APTIMA HPV Assay 10/28/2011 Completed
H100006 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM (DPS) Anesthesiology 09/28/2011 OSB Lead-NeuRx DPS 09/28/2011 Progress Adequate
P070014
S022
BARD PERIPHERAL VASCULAR, INC. BARD LIFESTENT VASCULAR STENT SYSTEMS Cardiovascular 09/16/2011 OSB Lead-LifeStent SOLO 07/11/2014 Progress Adequate
P110001 ABBOTT VASCULAR RX HERCULINK ELITE RENAL STENT SYSTEM Cardiovascular 07/20/2011 HERCULES PAS 06/26/2012 Completed
P090002 DEPUY ORTHOPAEDICS, INC. PINNACLE COMPLETE ACETABULAR HIP SYSTEM Orthopedic 06/13/2011 Pinnacle CoMplete Acetabular Hip System 11/04/2011 Terminated
P040013
S016
Luitpold Pharmaceuticals, Inc. GEM 21S GROWTH FACTOR ENHANCED MATRIX Dental 05/27/2011 OSB Lead-GEM21S Growth Factor 12/06/2011 Completed
P100014 VALEANT PHARMACEUTICALS NORTH AMERICA, LLC SOLESTA INJECTABLE GEL Gastroenterology/
Urology
05/27/2011 OSB Lead-Solesta - Long Term Study 02/26/2014 Progress Adequate
P070015
S054
ABBOTT VASCULAR INC. XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 05/24/2011 SPIRIT Small Vessel (SV) Registry 05/24/2011 Completed
P040012
S034
ABBOTT VASCULAR RX ACCULINK CAROTID STENT SYSTEM Cardiovascular 05/06/2011 OSB Lead-CANOPY Trial 03/04/2016 Progress Adequate
P930014
S045
Alcon Research, Ltd. ACRYSOF TORIC IOL & ACRYSOF IQ TORIC IOL Ophthalmic 05/03/2011 OSB Lead-New Enrollment PAS 09/18/2015 Progress Adequate
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) 04/22/2011 Completed
ION Post Approval Study 12/18/2014 Completed
P100029 St. Jude Medical, Inc. ST JUDE MEDICAL TRIFECTA VALVE Cardiovascular 04/20/2011 Trifecta Valve PAS 04/20/2011 Completed
P100020 Roche Molecular Systems, Inc. COBAS HPV TEST Microbiology 04/19/2011 MWP-HPV-159 04/19/2011 Completed
P100034 Novocure, Ltd. NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT Neurology 04/08/2011 OSB Lead-New Enrollment Study for NovoTTF-100A 02/09/2016 Revised/Replaced Study
OSB Lead-Registry Study for Optune System 02/09/2016 Study Pending
P100018 MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR PIPELINE EMBOLIZATION DEVICE Neurology 04/06/2011 OSB Lead-Continued Follow-up of Premarket Cohort 06/27/2011 Progress Adequate
H100002 NEUROVASX CPAX ANEURYSM TREATMENT SYSTEM Neurology 04/01/2011 New Enrollment Study 09/12/2012 Other
P080006
S002
MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD Cardiovascular 04/01/2011 OSB Lead-Chronic Lead Performance 04/01/2011 Progress Adequate
P100040 Medtronic Vascular VALIANT THORACIC STENT GRAFT SYSTEM Cardiovascular 04/01/2011 Captivia Delivery System 09/14/2011 Completed
P080006
S004
MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD Cardiovascular 03/31/2011 OSB Lead-Attain Ability Straight Model 4396 06/29/2015 Progress Adequate
P080025 MEDTRONIC NEUROMODULATION MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM Gastroenterology/
Urology
03/14/2011 FI-PAS 03/14/2011 Completed
H080005 ELANA INC. ELANA ARTERIOTOMY SYSTEM Neurology 03/10/2011 OSB Lead-Elana Surgical KitHUD 01/03/2012 Other
P000008
S017
APOLLO ENDOSURGERY INC LAP-BAND Gastroenterology/
Urology
02/16/2011 OSB Lead-LBMI-002 08/15/2011 Completed
OSB Lead-Apollo-001 03/03/2016 Progress Inadequate
P090013 Medtronic, Inc REVO MRI SURESCAN IPG AND PACING SYSTEM Cardiovascular 02/08/2011 OSB Lead-Chronic Lead Performance/Multiple MRI 02/08/2011 Progress Adequate
P100028 COOK MEDICAL INCORPORATED FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM Cardiovascular 01/14/2011 REFORM 12/05/2011 Completed
P070014
S010
BARD PERIPHERAL VASCULAR, INC. LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS Cardiovascular 12/23/2010 OSB Lead-CONTINUUM Long Lesion 07/11/2014 Progress Adequate
P070026 DEPUY ORTHOPAEDICS, INC. CERAMAX CERAMIC HIP SYSTEM Orthopedic 12/23/2010 OSB Lead-Ceramax PAS 03/18/2015 Progress Inadequate
P890055
S026
CODMAN CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP General Hospital 12/17/2010 OSB Lead-Long-Term Surveillance of MedStream 03/15/2011 Other
OSB Lead-Leachables Study 03/15/2011 Progress Adequate
OSB Lead-Drug Stability Study 03/15/2011 Progress Adequate
P100010 Medtronic CryoCath LP ARCTIC FRONT CRYOCATHETER SYSTEM Cardiovascular 12/17/2010 OSB Lead-STOP AF PAS 12/18/2013 Progress Adequate
P100021 Medtronic Vascular MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM Cardiovascular 12/16/2010 OSB Lead-ENGAGE 01/24/2014 Progress Adequate
P960040
S198
BOSTON SCIENTIFIC TELIGEN 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 12/21/2012 Progress Adequate
P010012
S212
Boston Scientific Corp. COGNIS 4-SITE MODELS Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P910073
S077
BOSTON SCIENTIFIC ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES Cardiovascular 11/10/2010 OSB Lead-Longitudinal Surveillance Study 01/14/2011 Progress Adequate
P830060
S062
BOSTON SCIENTIFIC LEAD TUNNELER MODEL 6888 Cardiovascular 11/10/2010 Longitudinal Surveillance Study 01/14/2011 Terminated
P010012
S230
Boston Scientific Corp. BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) Cardiovascular 09/16/2010 OSB Lead-MADIT-CRT ACC NCDR 01/18/2013 Progress Inadequate
OSB Lead-MADIT-CRT Registry 09/27/2011 Completed
P050034 VISION CARE OPHTHALMIC TECHNOLOGIES, LTD. IMPLANTABLE MINIATURE TELESCOPE (IMT) Ophthalmic 07/01/2010 OSB Lead-IMT PAS 01 New Enrollment Study 01/27/2015 Progress Adequate
OSB Lead-Premarket Cohort IMT-002-LTME 10/13/2010 Completed
P030054
S130
St. Jude Medical QUICKFLEX U MODEL 1258T LEAD Cardiovascular 05/10/2010 OSB Lead-QuickFlex u Model 1258T LV lead 05/10/2010 Progress Adequate
P080032 Boston Scientific Corp. ALAIR BRONCHIAL THERMOPLASTY SYSTEM Anesthesiology 04/27/2010 OSB Lead-AIR2 - Extended Study 07/27/2010 Completed
OSB Lead-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
P090018 ENVOY MEDICAL CORPORATION ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM Ear Nose & Throat 03/17/2010 OSB Lead-Extended Follow-up of PMA study 08/16/2010 Completed
OSB Lead-New Enrollment 03/18/2016 Revised/Replaced Study
Esteem New Enrollment 2 03/18/2016 Progress Adequate
P070027
S011
Medtronic Vascular TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 02/04/2010 OSB Lead-Registry 07/16/2014 Other
H080002 Medtronic, Inc MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM Cardiovascular 01/25/2010 Long Term PAS 09/24/2013 Terminated
Generalizability Study 09/24/2013 Terminated
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
P010047 NEOMEND, INC. PROGEL PLEURAL AIR LEAK SEALANT Anesthesiology 01/14/2010 OSB Lead-Long Term Safety 03/16/2015 Progress Adequate
P040003
S006
INSIGHTEC, LTD EXABLATE 2100 SYSTEM Obstetrics/
Gynecology
12/22/2009 Exablate 2100 Type 1.0 04/19/2010 Completed
P030042 MicroPort Orthopedics Inc. CONSERVE PLUS TOTAL RESURFACING HIP SYSTEM Orthopedic 11/03/2009 ConservePlus Longer-Term PAS 07/16/2010 Terminated
ConservePlus New Enrollment PAS 06/21/2010 Terminated
P020026
S017
CORDIS CORP. RAPTORRAIL RX SDS, 2.25MM CYPHER STENT Cardiovascular 09/18/2009 OSB Lead-CYPHER MINI 10/10/2014 Progress Adequate
P080013 INTEGRA LIFESCIENCES CORPORATION DURASEAL EXACT SPINE SEALANT SYSTEM Neurology 09/04/2009 OSB Lead-DuraSeal Exact Spine Sealant System 02/03/2016 Progress Adequate
P030050
S002
Q-Med AB SCULPTRA AESTHETIC General &
Plastic Surgery
07/28/2009 OSB Lead-Pre Clinical PAS 09/09/2010 Completed
OSB Lead-Clinical PAS 04/23/2014 Progress Adequate
P060008
S011
Boston Scientific Corp. TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 07/13/2009 TAXUS Long (S011) 07/23/2010 Completed
P070022 HOLOGIC, INC. ADIANA PERMANENT CONTRACEPTION SYSTEM Obstetrics/
Gynecology
07/06/2009 EASE TRIAL 07/06/2009 Terminated
P050050 STRYKER CORPORATION SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) Orthopedic 05/27/2009 OSB Lead-Long Term Study 05/09/2014 Progress Inadequate
OSB Lead-Actual Conditions of Use Study 11/23/2010 Progress Inadequate
P060008
S008
Boston Scientific Corp. TAXUS LIBERTE ATOM PACLITAXEL-ELUTING CORONARY STENT SYSTEM Cardiovascular 05/21/2009 TAXUS ATLAS Small Vessel 07/23/2009 Completed
P060023 Medtronic Sofamor Danek USA, Inc. BRYAN CERVICAL DISC PROSTHESIS Orthopedic 05/12/2009 OSB Lead-Long-Term Study 05/12/2009 Progress Adequate
OSB Lead-Enhanced Surveillance 05/12/2009 Progress Adequate
P860057
S042
EDWARDS LIFESCIENCES, LLC. CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS Cardiovascular 05/07/2009 OSB Lead-Clinical Study 11/03/2009 Progress Adequate
P080006 MEDTRONIC Inc. MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD Cardiovascular 04/07/2009 OSB Lead-Elution 04/07/2009 Completed
OSB Lead-Chronic Lead Performance 12/05/2013 Progress Inadequate
P000032
S028
CooperSurgical, Inc. HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM Obstetrics/
Gynecology
03/27/2009 Her Option PAS 03/27/2009 Completed
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
P070005 PATHFINDER CELL THERAPY INC. REPEL-CV BIORESORBABLE ADHESION BARRIER Cardiovascular 03/06/2009 REPEL CV 03/06/2009 Other
P000049
S016
NMT MEDICAL, INC. STARFLEX SEPTAL OCCLUSION SYSTEM Cardiovascular 03/05/2009 Fatigue & Corrosion Testing 03/05/2009 Other
P070014 BARD PERIPHERAL VASCULAR, INC. LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM Cardiovascular 02/13/2009 OSB Lead-CONTINUUM 07/11/2014 Progress Adequate
OSB Lead-RESILIENT 02/13/2009 Completed
P030031
S011
BIOSENSE WEBSTER, INC. NAVISTAR & CELSIUS THERMOCOOL CATHETERS Cardiovascular 02/06/2009 OSB Lead-CABANA Trial 11/24/2009 Progress Adequate
OSB Lead-Atrial Fibrillation Registry 09/23/2011 Progress Adequate
P910023
S154
St. Jude Medical PROMOTE CRT-D SYSTEM Cardiovascular 01/13/2009 OSB Lead-SJ4 PAS 09/09/2010 Completed
P030054
S067
St. Jude Medical ATLAS II + HF CRT-D SYSTEM Cardiovascular 01/13/2009 OSB Lead-SJ4 Post Approval Study 05/07/2009 Completed
P950022
S042
St. Jude Medical, Inc. RIATA ST OPTIM AND RIATA STS OPTIM Cardiovascular 01/13/2009 OSB Lead-SJ4 PAS 05/07/2009 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
P060025 MEDTRONIC Inc. ATS 3F AORTIC BIOPROSTHESIS Cardiovascular 10/30/2008 OSB Lead-ATS 3f 10/13/2015 Other
H060002 SPIRATION, INC. IBV VALVE SYSTEM Anesthesiology 10/24/2008 OSB Lead-IBV Valve 12/16/2014 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
P060008 Boston Scientific Corp. TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 10/10/2008 OSB Lead-Outcomes TAXUS ATLAS 10/10/2008 Completed
OSB Lead-TAXUS Registry 09/29/2014 Completed
OSB Lead-Dual Antiplatelet Study 01/21/2014 Completed
OSB Lead-Fatigue & Stability Testing 10/10/2008 Progress Adequate
H070004 THORATEC CORP. CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) Cardiovascular 10/07/2008 Centrimag PAS 05/22/2009 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
P860057
S029
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX Cardiovascular 08/29/2008 OSB Lead-Long Term 01/24/2014 Progress Adequate
P010031
S104
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CONCERTO/INSYNC SENTRY/INSYNC MAXIMO Cardiovascular 08/28/2008 Enhanced Surveillance 08/28/2008 Completed
P980016
S135
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR Cardiovascular 08/28/2008 Enhanced Surveillance 08/28/2008 Completed
P070015 ABBOTT VASCULAR INC. XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS Cardiovascular 07/02/2008 Longterm IDE Follow up 07/02/2008 Completed
XIENCE Registry 07/02/2008 Completed
Dual Antiplatelet Therapy 07/02/2008 Completed
Fatigue Testing 07/02/2008 Completed
P070013 COLBAR LIFESCIENCE LTD. EVOLENCE COLLAGEN FILLER General &
Plastic Surgery
06/27/2008 EVOLENCE 09/15/2008 Terminated
P060039 MEDTRONIC Inc. ATTAIN STARFIX MODEL 4195 LEAD Cardiovascular 06/13/2008 OSB Lead-Chronic Extraction 09/12/2014 Completed
OSB Lead-Chronic Performance Study 11/19/2013 Progress Adequate
P070007 Medtronic Vascular TALENT THORACIC STENT GRAFT SYSTEM Cardiovascular 06/05/2008 OSB Lead-THRIVE Trial 04/05/2016 Terminated
P070016 WILLIAM COOK EUROPE APS ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM Cardiovascular 05/21/2008 OSB Lead-Longterm PAS 11/26/2008 Progress Adequate
P010012
S160
Boston Scientific Corp. ACUITY SPIRAL HEART FAILURE LEAD MODELS, 4591, 4592 AND 4593 Cardiovascular 05/16/2008 OSB Lead - ACUITY Long-Term Registry 06/25/2009 Progress Inadequate
P060027 SORIN GROUP CRM USA, INC OVATIO CRT SYSTEM Cardiovascular 05/15/2008 Long Term 10/31/2008 Other
P980035
S073
MEDTRONIC Inc. MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE Cardiovascular 05/13/2008 OSB Lead-Longterm Study PAS 05/13/2008 Completed
P890003
S119
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT CARELINK MONITOR MODEL 2490H Cardiovascular 05/13/2008 OSB Lead-Longterm PAS 05/13/2008 Completed
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 OSB Lead-CELESTIAL Study 12/23/2010 Progress Adequate
P060040 THORATEC CORP. THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM Cardiovascular 04/21/2008 INTERMACS Registry 04/21/2008 Completed
P070027 Medtronic Vascular THE TALENT ABDOMINAL STENT GRAFT SYSTEM Cardiovascular 04/15/2008 OSB Lead-Vitality Trial 11/05/2008 Completed
P060033 MEDTRONIC Inc. ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM Cardiovascular 02/01/2008 5yr Clinical Outcomes 02/01/2008 Completed
Registry PROTECT CA 09/16/2008 Completed
Dual Antiplatelet Therapy EDUCATE 02/01/2008 Completed
Product Testing 02/01/2008 Completed
P070001 SYNTHES SPINE PRODISC TM-C TOTAL DISC REPLACEMENT Orthopedic 12/17/2007 OSB Lead-Long Term Study 08/12/2008 Progress Adequate
OSB Lead-Enhanced Surveillance Study 08/12/2008 Completed
P060037 ZIMMER, INC. NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM Orthopedic 12/10/2007 OSB Lead-Long Term Study 08/14/2014 Progress Inadequate
P870072
S037
THORATEC LABORATORIES CORP. THORATEC TLC-II PORTABLE VAD DRIVER Cardiovascular 11/14/2007 OSB Lead-Thoratec TLC-ii portable 11/14/2007 Progress Adequate
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 10/23/2007 Completed
EMERGE 10/23/2007 Terminated
P070009 OBTECH MEDICAL GMBH REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X Gastroenterology/
Urology
09/28/2007 OSB Lead-Realize PAS 09/09/2008 Progress Adequate
P040040 AGA MEDICAL CORP. AMPLATZER MUSCULAR VSD OCCLUDER Cardiovascular 09/07/2007 OSB Lead-5 year long term (IDE) 09/07/2007 Terminated
OSB Lead-Post Approval Study 03/18/2016 Progress Inadequate
P040013
S009
Luitpold Pharmaceuticals, Inc. GEM 21S (GROWTH ENHANCED MATRIX) Dental 08/10/2007 Working Standard for Biomatrix 08/25/2008 Completed
P050024 Boston Scientific Corp. CRYOCOR CRYOABLATION SYSTEM Cardiovascular 08/01/2007 Cryocor Ablation PAS 03/13/2008 Terminated
P060002 BARD PERIPHERAL VASCULAR FLAIR ENDOVASCULAR STENT GRAFT Cardiovascular 07/23/2007 FLAIR Endovascular Grafts 03/13/2008 Completed
P060017 JANSSEN DIAGNOSTICS GENESEARCH BREAST LYMPH NODE(BLN) ASSAY Pathology 07/16/2007 PPC Study 10/29/2007 Other
TS Study 10/29/2007 Other
P060018 MEDTRONIC SOFAMOR DANEK, INC. PRESTIGE CERVICAL DISC SYSTEM Orthopedic 07/16/2007 OSB Lead-Long-Term Study 07/16/2007 Completed
OSB Lead-Enhanced Surveillance 07/16/2007 Completed
P930016
S025
AMO Manufacturing USA, LLC STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM Ophthalmic 07/11/2007 OSB Lead-Star 4 Monovision Lasik 04/02/2008 Other
P970021
S014
GYNECARE, INC. GYNECARE THERMACHOICE III UTERINE BALLOON THERAPY SYSTEM Obstetrics/
Gynecology
07/06/2007 Long-Term Study 01/29/2008 Completed
P050039 EXACTECH, INC. NOVATION CERAMIC ARTICULATION HIP SYSTEM Orthopedic 07/05/2007 OSB Lead-Long Term 12/09/2010 Revised/Replaced Study
OSB Lead-Novation PAS 12/09/2010 Progress Adequate
P050016 CORIN U.S.A. CORMET HIP RESURFACING SYSTEM Orthopedic 07/03/2007 OSB Lead-Long Term Study 11/04/2008 Progress Adequate
OSB Lead-New Enrollment 11/04/2008 Progress Adequate
P020014
S012
BAYER PHARMA AG CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL Obstetrics/
Gynecology
06/15/2007 ESS-305 06/15/2007 Completed
P060001 MEDTRONIC VASCULAR INC PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEMS Cardiovascular 01/24/2007 CREATE PAS 08/02/2007 Completed
CREATE (IDE) 08/02/2007 Completed
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
P050033 Anika Therapeutics, Inc. HYDRELLE General &
Plastic Surgery
12/20/2006 Elevess CTA Study 04/29/2008 Completed
P040025 Natus Medical Incorporated OLYMPIC COOL-CAP Neurology 12/20/2006 VON Registry 12/20/2006 Completed
P020056 Allergan NATRELLE SILICONE-FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-BIFS (Large PAS) 08/03/2015 Progress Inadequate
OSB Lead-Core 11/17/2006 Completed
OSB Lead-Focus Group 11/17/2006 Completed
OSB Lead-Adjunct 11/17/2006 Completed
OSB Lead-Device failure Study 11/17/2006 Other
OSB Lead-Informed Decision Process 10/17/2006 Completed
OSB Lead-Re-Op Phase 01/16/2015 Progress Adequate
OSB Lead-Natrelle and 410 Combined Cohort 08/03/2015 Study Pending
P030053 MENTOR CORP. MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS General &
Plastic Surgery
11/17/2006 OSB Lead-Large PAS 10/01/2014 Revised/Replaced Study
OSB Lead-Device Failure Study 11/17/2006 Other
OSB Lead-Informed Decision Process 11/17/2006 Completed
OSB Lead-Adjunct Study 11/17/2006 Completed
OSB Lead-Core 11/17/2006 Completed
OSB Lead-Focus Group 11/17/2006 Completed
OSB Lead-Breast Implant Case Control Studies 04/18/2014 Terminated
OSB Lead-MemoryGel and Shape Combined Cohort 02/12/2016 Study Pending
OSB Lead-Re-Op Phase 01/16/2015 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 06/06/2007 Completed
P040050 UROPLASTY, LLC MACROPLASTIQUE IMPLANTS Gastroenterology/
Urology
10/30/2006 OSB Lead-5 year registry - ROSE 10/30/2006 Progress Adequate
OSB Lead-Enhanced Surveillance 10/30/2006 Completed
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
P020012 SUNEVA MEDICAL, INC. ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER General &
Plastic Surgery
10/27/2006 Study P521-01 10/27/2006 Completed
P000053
S005
Boston Scientific Corp. SPHINCTER 800 URINARY CONTROL SYSTEM Gastroenterology/
Urology
10/13/2006 Registry AMS MC-0611 02/07/2007 Completed
P030047 CORDIS CORP. CORDIS PRECISE NITINOL STENT SYSTEM Cardiovascular 09/22/2006 Longterm & CASES Studies 09/22/2006 Completed
P020018
S010
COOK, INC. 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT Cardiovascular 09/07/2006 AAA Flex 36mm 09/07/2006 Completed
H040006 ABIOMED, INC. ABIOCOR IMPLANTABLE REPLACEMENT HEART Cardiovascular 09/05/2006 Abiocor Artificial Heart 09/05/2006 Other
P050010 SYNTHES SPINE PRODISC -L TOTAL DISC REPLACEMENT DEVICE Orthopedic 08/14/2006 PRODISC-L Long Term Study 08/14/2006 Completed
P050006 W.L. GORE & ASSOCIATES,INC GORE HELEX SEPTAL OCCLUDER Cardiovascular 08/11/2006 GORE HELEX 12/13/2006 Completed
P040036 BIOSENSE WEBSTER, INC. NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER Cardiovascular 08/11/2006 NaviStar Study 08/11/2006 Completed
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
P040048 ZIMMER, INC. TRILOGY AB ACETABULAR SYSTEM Orthopedic 06/28/2006 OSB Lead-Long term 06/28/2006 Revised/Replaced Study
OSB Lead-Trilogy PAS 06/04/2010 Terminated
P040051 STELKAST COMPANY STELKAST SURPASS ACETABULAR SYSTEM Orthopedic 05/12/2006 OSB Lead-Long term 05/12/2006 Revised/Replaced Study
OSB Lead-Stelkast Surpass Active PAS 04/22/2011 Terminated
P040033 SMITH&NEPHEW ORTHOPAEDICS BIRMINGHAM HIP RESURFACING (BHR) SYSTEM Orthopedic 05/09/2006 OSB Lead-US Study 05/09/2006 Progress Adequate
OSB Lead-UK Study 05/09/2006 Completed
P980049
S020
SORIN GROUP- CRM 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
P040028 SPECTRA SCIENCE LUMA CERVICAL IMAGING SYSTEM Obstetrics/
Gynecology
03/16/2006 OSB Lead-LUMA 03/16/2006 Terminated
P910023
S088
St. Jude Medical EPIC II VR, EPIC II DR, AND EPIC II+ DR IMPLANTABLE CARDIOVERTER DEFIBRILLATORS Cardiovascular 03/14/2006 EPIC Notifiers 03/14/2006 Completed
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
P040052 HOLOGIC, INC. MONOPREP PAP TEST Pathology 03/03/2006 CHOICE Study 12/18/2007 Other
SURE Study 10/18/2007 Completed
P030016 STAAR SURGICAL CO. VISIAN ICL (IMPLANTABLE COLLAMER LENS) Ophthalmic 12/22/2005 OSB Lead-Adverse Event Study 06/08/2012 Progress Adequate
OSB Lead-Follow-up Study 12/22/2005 Completed
OSB Lead-Axial Lengths 12/22/2005 Completed
P050009 Biomet, Inc. C2 A-TAPER ACETABULAR SYSTEM Orthopedic 12/16/2005 OSB Lead-Long Term Study 12/16/2005 Terminated
P040001 MEDTRONIC SOFAMOR DANEK, INC. X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM Orthopedic 11/21/2005 LTOS Study 12/08/2006 Completed
COAST Study 10/24/2014 Terminated
P040047 MERZ NORTH AMERICA, INC COAPTITE Gastroenterology/
Urology
11/10/2005 OSB Lead-Coaptite 09/29/2008 Progress Adequate
P020016 BIOMET MICROFIXATION, INC. WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM Dental 09/21/2005 Longterm Followup Study 09/21/2005 Completed
P040038 ABBOTT VASCULAR INC. XACT CAROTID STENT SYSTEM Cardiovascular 09/06/2005 PROTECT Study 02/05/2007 Completed
EXACT Study 10/12/2005 Completed
P980022
S012
MEDTRONIC MINIMED GUARDIAN RT Clinical Chemistry 08/24/2005 PXX/GS041/A 12/27/2006 Completed
P040021 St. Jude Medical, Inc. SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE Cardiovascular 08/05/2005 OSB Lead-Biocor & Biocor Supra Valves 08/30/2012 Completed
P030004 EV3 NEUROVASCULAR ONYX LIQUID EMBOLIC SYSTEM Neurology 07/21/2005 Long Term Study 07/21/2005 Completed
P970003
S050
Cyberonics, Inc. VNS THERAPY SYSTEM Neurology 07/15/2005 OSB Lead-Registry Study 06/04/2015 Progress Adequate
OSB Lead-Dosing Study D-21 07/15/2005 Completed
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
P040023 DEPUY ORTHOPAEDICS, INC. DURALOC OPTION CERAMIC HIP SYSTEM Orthopedic 05/03/2005 OSB Lead-Duraloc Long Term 05/03/2005 Revised/Replaced Study
OSB Lead-Prospective Post-Approval Study 04/20/2010 Terminated
OSB Lead-DePuy Outcome Tracking Sys Registry(DOTS) 04/20/2010 Terminated
OSB Lead-Kaiser Permanente Joint Registry 04/20/2010 Terminated
OSB Lead-Natl Joint Registry for England and Wales 04/20/2010 Terminated
OSB Lead-Australian Ortho Assc Natl Joint Registry 04/20/2010 Terminated
OSB Lead-New England Bapt Hospital Joint Registry 06/12/2012 Terminated
P040016 BOSTON SCIENTIFIC SCIMED, INC. VERIFLEX (LIBERTE) BARE-METAL CORONARY STEM SYSTEM Cardiovascular 04/12/2005 Longterm Outcomes 04/12/2005 Completed
P040034 INTEGRA LIFESCIENCES CORPORATION DURASEAL DURAL SEALANT SYSTEM Neurology 04/07/2005 Duraseal 04/07/2005 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
P040024 Q-Med AB RESTYLANE INJECTABLE GEL General &
Plastic Surgery
03/25/2005 Restylane 03/25/2005 Completed
P040043 W. L. GORE & ASSOCIATES, INC. GORE TAG THORACIC ENDOPROSTHESIS Cardiovascular 03/23/2005 Cohort Study 08/31/2005 Completed
Training Study 08/31/2005 Completed
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
P030022 Smith & Nephew, Inc. REFLECTION CERAMIC ACETABULAR SYSTEM Orthopedic 12/17/2004 OSB Lead-Reflection Long Term 12/17/2004 Progress Adequate
P030030 C.R. Bard, Inc. URYX URETHRAL BULKING AGENT Gastroenterology/
Urology
12/16/2004 Tegress PAS 12/16/2004 Terminated
P030031 BIOSENSE WEBSTER, INC. BIOSENSE WEBSTER NAVISTAR/CELSIUS THERMO COOL DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETERS Cardiovascular 11/05/2004 Navastar Thermocool 12/19/2005 Completed
P040002 ENDOLOGIX, INC. ENDOLOGIX POWERLINK SYSTEM Cardiovascular 10/29/2004 Long Term/Pivotal Cohort Completed
P040006 DEPUY SPINE,INC CHARITE ARTIFICIAL DISC Orthopedic 10/26/2004 OSB Lead-Charite Artificial Disc 10/26/2004 Terminated
P040003 INSIGHTEC, LTD EXABLATE 2000 SYSTEM Obstetrics/
Gynecology
10/22/2004 Long Term Exablate Study 10/22/2004 Completed
P030011 SYNCARDIA SYSTEMS, INC. SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T) Cardiovascular 10/15/2004 OSB Lead-Long Term 01/04/2011 Completed
P040029 Euclid Systems Corporation JSZ ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR Ophthalmic 09/29/2004 OSB Lead-JSZ Orthokeratology Contact Lenses 09/29/2004 Completed
P030028 OPHTEC BV ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL) Ophthalmic 09/10/2004 OSB Lead-Long Term 11/10/2011 Progress Adequate
OSB Lead-ECD Study 09/10/2004 Progress Adequate
P030050 Q-Med AB SCULPTRA AND SCULPTRA AESTHETIC General &
Plastic Surgery
08/03/2004 Long Term Registry 08/17/2009 Completed
P870072
S027
THORATEC LABORATORIES CORP. THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) Cardiovascular 08/03/2004 Thoratec IVAD 08/03/2004 Completed
P020014
S006
BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology
07/22/2004 HSG Evaluation Study 07/22/2004 Completed
P030054 St. Jude Medical ST JUDE MEDICAL EPIC HF SYSTEM Cardiovascular 06/30/2004 Long Term Completed
P010062 BAUSCH & LOMB EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR Ophthalmic 06/07/2004 Long term 06/07/2007 Completed
P020004
S006
W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROTHESIS Cardiovascular 06/02/2004 Long Term Follow up 06/02/2004 Completed
P030035 St. Jude Medical, Inc. ANTHEM AND FRONTIER II CRT-P'S Cardiovascular 05/13/2004 Long term Completed
P030032 GENZYME BIOSURGERY HYLAFORM (HYLAN B GEL) General &
Plastic Surgery
04/22/2004 Fitzpatrick skin types 04/22/2004 Completed
P010014 BIOMET MANUFACTURING CORP. OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM Orthopedic 04/21/2004 OSB Lead-Long Term PAS 01/04/2013 Progress Adequate
P030025 Boston Scientific Corp. TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) Cardiovascular 03/04/2004 ARRIVE I 03/04/2004 Completed
TAXUS (IDE) Completed
H030003 RELIANTHEART INC. DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEM Cardiovascular 02/25/2004 OSB Lead-HeartAssist 5 Pediatric VAD 10/01/2010 Progress Inadequate
P030006 MEDIFOCUS, INC PROLIEVE THERMODILATATION SYSTEM Gastroenterology/
Urology
02/19/2004 OSB Lead-Prolieve PAS 03/11/2005 Progress Adequate
N980003 DJO SURGICAL KERAMOS CERAMIC/CERAMIC TOTAL HIP SYSTEM Orthopedic 11/26/2003 Encore Keramos PDP Study Completed
P860057
S018
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS, MODEL 3000 AORTIC Cardiovascular 11/14/2003 Perimount Magna Pericardial Bioprosthesis Completed
P020031 MICROSULIS MEDICAL LTD. MICROSULIS MICROWAVE ENDOMETRIAL ABLATION (MEA) SYSTEM Obstetrics/
Gynecology
09/23/2003 MEA PAS 09/23/2003 Completed
P860004
S056
MEDTRONIC Inc. SYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM General Hospital 09/12/2003 Synchromed II 09/12/2003 Completed
P870056
S015
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS BIOPROSTHESES, MODELS 2625 (AORTIC) & 6625 (MITRAL), AND CARPENTIER-EDWARDS BIOPROSTHETIC VALVED COND Cardiovascular 08/22/2003 Tag Alert Completed
P030027 MicroPort Orthopedics Inc. CERAMIC TRANSCEND HIP ARTICULATION Orthopedic 07/07/2003 Ceramic Transcend Hip 01/07/2003 Completed
P020024 AGA MEDICAL CORP. AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM Cardiovascular 05/14/2003 Long term 05/14/2003 Completed
P860057
S019
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 05/09/2003 PERIMOUNT Plus Pericardial Bioprosthesis Model 6900P Completed
P010041
S002
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. PORCINE BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2003 Completed
P870077
S013
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2007 Completed
P000007
S003
EDWARDS LIFESCIENCES, LLC. EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS Cardiovascular 05/09/2003 Tag Alert 05/09/2003 Completed
P020026 CORDIS CORP. CYPHER SIROLIMUS-ELUTING CORONARY STENT ON THE RAPTOR OVER-THE-WIRE DELIVERY SYSTEM OR RAPTORRAIL RAPID EXCHANGE DELIVER Cardiovascular 04/24/2003 Bench Testing 04/24/2003 Completed
P020006 Boston Scientific Corp. ENTERYX PROCEDURE KIT Gastroenterology/
Urology
04/22/2003 Enteryx 12/27/2007 Terminated
P020045 Medtronic CryoCath LP 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM Cardiovascular 04/17/2003 CryoFACTS 04/17/2003 Completed
P980035
S013
MEDTRONIC Inc. MEDTRONIC AT500 DDDRP PACING SYSTEM (MODEL AT501) AND MODEL 9968 SOFTWARE Cardiovascular 03/26/2003 RESPECT 10/03/2003 Completed
P010001 CERAMTEC GMBH CERAMIC TRANSCEND HIP ARTICULATION SYSTEM Orthopedic 02/03/2003 Ceramic Transcend Hip Completed
P000013 HOWMEDICA OSTEONICS CORP. TRIDENT SYSTEM Orthopedic 02/03/2003 Osteonics Long Term 08/16/2003 Completed
P020004 W.L. GORE & ASSOCIATES,INC EXCLUDER BIFURCATED ENDOPROSTHESIS Cardiovascular 11/06/2002 PAS Completed
P920014
S016
THORATEC CORP. THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM (SNAP VE LVAS) Cardiovascular 11/06/2002 Continued Access/Registry/IDE 11/06/2002 Completed
P020014 BAYER PHARMA AG ESSURE SYSTEM Obstetrics/
Gynecology
11/04/2002 Newly Trained Physicians 11/04/2002 Completed
5 year follow up 11/04/2002 Completed
P970004
S022
MEDTRONIC NEUROMODULATION INTERSTIM THERAPY FOR URINARY CONTROL Gastroenterology/
Urology
09/24/2002 OSB Lead-Urgency Frequency (UF 1635) 10/23/2007 Revised/Replaced Study
OSB Lead-Urinary Urge Incontinence (UUI) 10/23/2007 Revised/Replaced Study
OSB Lead-Single Tined Lead (protocol 1634) 04/02/2010 Progress Adequate
P830063
S002
BAXTER INTERNATIONAL, INC. GAMBRO PRISMA TPE 2000 SET WITH PLASMAFILTER PF2000N Gastroenterology/
Urology
08/28/2002 Gambro PAS Completed
P010039 SIEMENS MEDICAL SOLUTIONS USA, INC. SIEMENS SONOCUR BASIC SYSTEM General &
Plastic Surgery
07/19/2002 Sonocur Terminated
P990018
S002
MENICON CO. LTD. MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR Ophthalmic 07/12/2002 Menicon RGP 07/12/2002 Terminated
P010041 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS S.A.V. BIOPROSTHESIS, MODEL 2650 (AORTIC) Cardiovascular 06/24/2002 Long term 06/24/2002 Completed
P960009
S007
MEDTRONIC Inc. MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM Neurology 01/14/2002 VA Study Completed
P000049 NMT MEDICAL, INC. CARDIOSEAL SEPTAL OCCLUSION SYSTEM WITH QWIKLOAD Cardiovascular 12/05/2001 Prospective VSD Registry 04/19/2002 Other
P000039 AGA MEDICAL CORP. THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM Cardiovascular 12/05/2001 Long term 08/16/2007 Completed
P860057
S016
EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS Cardiovascular 11/29/2001 PAS Completed
P980006
S004
Bausch & Lomb, Inc. PUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES Ophthalmic 11/20/2001 Long Term Completed
P000057 INTEGRA LIFESCIENCES CORPORATION ASCENSION MCP Orthopedic 11/19/2001 OSB Lead-Ascension MCPT 02/08/2002 Progress Inadequate
P000029 VALEANT PHARMACEUTICALS NORTH AMERICA, LLC DEFLUX INJECTABLE GEL REN Gastroenterology/
Urology
09/24/2001 Deflux Long-Term 09/24/2001 Completed
P010015 MEDTRONIC Inc. MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM Cardiovascular 08/28/2001 Registry 08/28/2001 Completed
P000008 APOLLO ENDOSURGERY INC LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM Gastroenterology/
Urology
06/05/2001 OSB Lead-Lap-Band Long Term 06/05/2001 Revised/Replaced Study
OSB Lead-HERO-002 03/28/2016 Progress Inadequate
P000035 NEXUS CMF, LLC TMJ FOSSA-EMINENCE PROSTHESIS(TM) Dental 02/27/2001 TMJ Completed
P000023 NEXUS CMF, LLC TMJ FOSSA-EMINENCE/CONDYLAR PROSTHESES Dental 01/05/2001 TMJ Fossa-Eminence PAS Completed
P000018 BEST VASCULAR, INC BETA-CATH (TM) SYSTEM Cardiovascular 11/03/2000 OSB Lead-Beta-Cath Long Term 02/23/2011 Progress Inadequate
P990036 CORDIS CORP. CORDIS CHECKMATE(TM) SYSTEM Cardiovascular 11/03/2000 PAS Completed
P990046 MEDTRONIC ATS MEDICAL, INC. ATS OPEN PIVOT BILEAFLET HEART VALVE Cardiovascular 10/13/2000 Wear testing 04/24/2009 Completed
P000006 COLOPLAST CORP. TITAN INFLATABLE PENILE PROSTHESIS Gastroenterology/
Urology
07/14/2000 Coloplast PAS Completed
P980050 MEDTRONIC Inc. MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF Cardiovascular 06/14/2000 RESPECT 03/26/2003 Completed
P990020 Medtronic Vascular ANEURX STENT GRAFT SYSTEM Cardiovascular 09/28/1999 Long term 09/28/1999 Completed
P950024
S002
MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/16/1999 Bipolar Model 4968 Completed
P980052 TMJ CONCEPTS TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS Dental 07/02/1999 Long term 07/02/1999 Completed
P970029 CRYOLIFE, INC. TMR HOLMIUM LASER SYSTEM Cardiovascular 02/11/1999 TMR 10/20/2009 Completed
P980003 Boston Scientific Corp. CHILLI COOLED RF ABLATION SYSTEM Cardiovascular 02/02/1999 PAS Completed
P950015 NOVADAQ CORP. THE HEART LASER TM CO2 LASER SYSTEM FOR TRANSMYOCARDIAL REVASCULARIZATION Cardiovascular 08/20/1998 Heart Laser CO2 Completed
P970030 St. Jude Medical, Inc. TORONTO SPV VALVE Cardiovascular 11/04/1997 PAS Completed
P940016 B. Braun Avitum AG H.E.L.P. SYSTEM Gastroenterology/
Urology
09/19/1997 Registry 09/19/1997 Completed
P960009 MEDTRONIC Inc. MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM Neurology 07/31/1997 Neurotoxicity/Carcinogenicity 04/16/2010 Completed
Mortality and Autopsy 04/16/2010 Completed
P950024 MEDTRONIC Inc. MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 Cardiovascular 09/06/1996 Unipolar Model 4965 Completed
P920023 Boston Scientific Corp. UROLUME ENDOPROSTHESIS Gastroenterology/
Urology
05/06/1996 Urolume PAS Completed
P940008 BOSTON SCIENTIFIC RES-Q(TM) ARRHYTHMIA CONTROL DEVICE EPICARDIAL PATCH AND NON-THORACOTOMY LEAD (NTL) SYSTEMS Cardiovascular 11/28/1995 PAS Completed
P900030 Allergan, Inc. CONTIGEN (TM) BARD (R) COLLAGEN IMPLANT Gastroenterology/
Urology
09/30/1993 Long term Cohort C Completed
P870077 EDWARDS LIFESCIENCES, LLC. CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE MITRAL BIOPROSTHESIS Cardiovascular 09/25/1991 PAS 09/25/1991 Completed

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