|
|
Application Number |
|
|
|
Applicant Name |
|
---|
|
|
Device Name |
|
---|
|
|
Medical Specialty |
|
---|
|
|
Date PMA Approved |
|
---|
|
|
|
|
P070015
S054
|
ABBOTT VASCULAR |
XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEM |
Cardiovascular |
05/24/2011 |
SPIRIT Small Vess (SV) Registry |
05/24/2011 |
Progress Adequate |
P110001
|
ABBOTT VASCULAR |
RX HERCULINK ELITE RENAL STENT SYSTEM |
Cardiovascular |
07/20/2011 |
HERCULES PAS |
06/26/2012 |
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 |
Progress Adequate |
P040012
S034
|
ABBOTT VASCULAR INC. |
RX ACCULINK CAROTID STENT SYSTEM |
Cardiovascular |
05/06/2011 |
CANOPY Trial |
05/06/2011 |
Progress Adequate |
P040038
|
ABBOTT VASCULAR INC. |
XACT CAROTID STENT SYSTEM |
Cardiovascular |
09/06/2005 |
PROTECT Study |
02/05/2007 |
Completed |
EXACT Study |
10/12/2005 |
Completed |
P070015
|
ABBOTT VASCULAR INC. |
XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS |
Cardiovascular |
07/02/2008 |
Longterm IDE Follow up |
07/02/2008 |
Progress Adequate |
XIENCE Registry |
07/02/2008 |
Progress Adequate |
Dual Antiplatelet Therapy |
07/02/2008 |
Progress Adequate |
Fatigue Testing |
07/02/2008 |
Completed |
H040006
|
ABIOMED, INC. |
ABIOCOR |
Cardiovascular |
09/05/2006 |
Abiocor Artificial Heart |
09/05/2006 |
Other |
P040040
|
AGA MEDICAL CORP. |
AMPLATZER MUSCULAR VSD OCCLUDER |
Cardiovascular |
09/07/2007 |
5 year long term (IDE) |
09/07/2007 |
Terminated |
Post Approval Study |
09/07/2007 |
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 Inadequate |
P020056
|
ALLERGAN |
NATRELLE SILICONE-FILLED BREAST IMPLANTS |
General & Plastic Surgery |
11/17/2006 |
BIFS (Large PAS) |
11/17/2006 |
Progress Inadequate |
Core |
11/17/2006 |
Progress Adequate |
Focus Group |
11/17/2006 |
Completed |
Adjunct |
11/17/2006 |
Progress Inadequate |
Device failure Study |
11/17/2006 |
Progress Adequate |
Informed Decision Process |
10/17/2006 |
Completed |
P000008
S017
|
ALLERGAN, INC. |
LAP-BAND |
Gastroenterology/ Urology |
02/16/2011 |
LBMI-002 |
08/15/2011 |
Progress Inadequate |
BOLD-001 |
11/17/2011 |
Progress Inadequate |
P000053
S005
|
AMERICAN MEDICAL SYSTEMS, INC. |
SPHINCTER 800 URINARY CONTROL SYSTEM |
Gastroenterology/ Urology |
10/13/2006 |
Registry AMS MC-0611 |
02/07/2007 |
Progress Adequate |
P000032
S028
|
AMERICAN MEDICAL SYSTEMS, INC. |
HER OPTION OFFICE CRYOABLATION THERAPY SYSTEM |
Obstetrics/ Gynecology |
03/27/2009 |
Her Option PAS |
03/27/2009 |
Completed |
P050033
|
ANIKA THERAPEUTICS, INC. |
HYDRELLE |
General & Plastic Surgery |
12/20/2006 |
Elevess CTA Study |
04/29/2008 |
Completed |
P100046
|
ATRICURE INC. |
ATRICURE SYNERGY ABLATION SYSTEM |
Cardiovascular |
12/14/2011 |
AtriCure Synergy Ablation System |
08/15/2012 |
Progress Adequate |
P060002
|
BARD PERIPHERAL VASCULAR |
FLAIR ENDOVASCULAR STENT GRAFT |
Cardiovascular |
07/23/2007 |
FLAIR Endovascular Grafts |
03/13/2008 |
Progress Adequate |
P070014
|
BARD PERIPHERAL VASCULAR, INC. |
LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM |
Cardiovascular |
02/13/2009 |
CONTINUUM |
10/18/2010 |
Progress Adequate |
RESILIENT |
02/13/2009 |
Completed |
P070014
S022
|
BARD PERIPHERAL VASCULAR, INC. |
BARD LIFESTENT VASCULAR STENT SYSTEMS |
Cardiovascular |
09/16/2011 |
LifeStent SOLO |
11/21/2011 |
Progress Adequate |
P070014
S010
|
BARD PERIPHERAL VASCULAR, INC. |
LIFESTENT AND LIFESTENT XL VASCULAR STENT SYSTEMS |
Cardiovascular |
12/23/2010 |
CONTINUUM Long Lesion |
03/17/2011 |
Progress Adequate |
H100004
|
BERLIN HEART INC. |
EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Cardiovascular |
12/16/2011 |
All Comers Registry |
07/27/2012 |
Study Pending |
P020016
|
BIOMET MICROFIXATION, INC. |
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM |
Dental |
09/21/2005 |
Longterm Followup Study |
09/21/2005 |
Completed |
P050009
|
BIOMET, INC. |
C2 A-TAPER ACETABULAR SYSTEM |
Orthopedic |
12/16/2005 |
Long Term Study |
12/16/2005 |
Progress Inadequate |
P040013
S009
|
BIOMIMETIC THERAPEUTICS, INC. |
GEM 21S (GROWTH ENHANCED MATRIX) |
Dental |
08/10/2007 |
Working Standard for Biomatrix |
08/25/2008 |
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 |
P040036
|
BIOSENSE WEBSTER, INC. |
NAVISTAR THERMOCOOL DEFLECTABLE DIAGNOSTIC/ABLATION CATHETER |
Cardiovascular |
08/11/2006 |
NaviStar Study |
08/11/2006 |
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 |
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 |
11/06/2008 |
Progress Adequate |
P110038
|
BOLTON MEDICAL, INC. |
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
Cardiovascular |
09/21/2012 |
Relay Thoracic Stent-Graft with Plus Delivery Syst |
12/18/2012 |
Study Pending |
P960040
S198
|
BOSTON SCIENTIFIC |
TELIGEN 4-SITE MODELS |
Cardiovascular |
11/10/2010 |
Longitudinal Surveillance Study |
01/14/2011 |
Study Pending |
P010012
S212
|
BOSTON SCIENTIFIC |
COGNIS 4-SITE MODELS |
Cardiovascular |
11/10/2010 |
Longitudinal Surveillance Study |
01/14/2011 |
Study Pending |
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 |
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 |
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 |
Outcomes TAXUS ATLAS |
10/10/2008 |
Completed |
TAXUS Registry |
10/10/2008 |
Progress Inadequate |
Dual Antiplatelet Study |
08/28/2010 |
Progress Adequate |
Fatigue & Stability Testing |
10/10/2008 |
Progress Inadequate |
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 |
P080032
|
BOSTON SCIENTIFIC CORP. |
ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
Anesthesiology |
04/27/2010 |
AIR2 - Extended Study |
07/27/2010 |
Progress Adequate |
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 |
07/16/2010 |
Progress Adequate |
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 |
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 |
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 |
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 |
P060008
S011
|
BOSTON SCIENTIFIC CORPORATION |
TAXUS LIBERTE' PACLITAXEL-ELUTING CORONARY STENT SYSTEM |
Cardiovascular |
07/13/2009 |
TAXUS Long (S011) |
07/23/2010 |
Completed |
P010012
S230
|
BOSTON SCIENTIFIC CORPORATION (BSC) |
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS) |
Cardiovascular |
09/16/2010 |
MADIT-CRT ACC NCDR |
09/16/2010 |
Progress Adequate |
MADIT-CRT Registry |
09/16/2010 |
Progress Adequate |
P040016
|
BOSTON SCIENTIFIC SCIMED, INC. |
VERIFLEX (LIBERTE) BARE-METAL CORONARY STEM SYSTEM |
Cardiovascular |
04/12/2005 |
Longterm Outcomes |
04/12/2005 |
Completed |
P110042
|
CAMERON HEALTH, INC |
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM |
Cardiovascular |
09/28/2012 |
S-ICD PAS Registry |
|
Study Pending |
P970029
S014
|
CARDIOGENESIS CORP. |
CARDIOGENESIS HOLMIUM TMR SYSTEM |
Cardiovascular |
02/22/2012 |
PEARL 8.0 New Enrollment Study |
05/25/2012 |
Progress Inadequate |
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 |
P890055
S026
|
CODMAN & SHURTLEFF, INC. |
CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP |
General Hospital |
12/17/2010 |
Long-Term Surveillance of MedStream |
03/15/2011 |
Study Pending |
Leachables Study |
03/15/2011 |
Progress Adequate |
Drug Stability Study |
03/15/2011 |
Progress Adequate |
P070013
|
COLBAR LIFESCIENCE LTD. |
EVOLENCE COLLAGEN FILLER |
General & Plastic Surgery |
06/27/2008 |
EVOLENCE |
09/15/2008 |
Terminated |
P020014
S017
|
CONCEPTUS, INC. |
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL |
Obstetrics/ Gynecology |
02/24/2012 |
Essure/post-NovaSure PAS |
02/24/2012 |
Study Pending |
P020014
S012
|
CONCEPTUS, INC. |
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL |
Obstetrics/ Gynecology |
06/15/2007 |
ESS-305 |
06/15/2007 |
Completed |
P020018
S040
|
COOK INCORPORATED |
ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT |
Cardiovascular |
04/04/2012 |
Long Term F/U Study |
12/12/2012 |
Study Pending |
Training Program |
10/01/2012 |
Study Pending |
P100028
|
COOK MEDICAL INCORPORATED |
FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM |
Cardiovascular |
01/14/2011 |
REFORM |
12/05/2011 |
Progress Adequate |
P100022
|
COOK MEDICAL INCORPORATED |
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT |
Cardiovascular |
11/14/2012 |
New US Enrollment |
|
Protocol Pending |
Zilver PTX Stent PAS |
|
Protocol Pending |
P020018
S010
|
COOK, INC. |
36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT |
Cardiovascular |
09/07/2006 |
AAA Flex 36mm |
09/07/2006 |
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 |
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 |
P020026
S017
|
CORDIS CORPORATION |
RAPTORRAIL RX SDS, 2.25MM CYPHER STENT |
Cardiovascular |
09/18/2009 |
CYPHER MINI |
08/17/2009 |
Progress Adequate |
P050016
|
CORIN U.S.A. |
CORMET HIP RESURFACING SYSTEM |
Orthopedic |
07/03/2007 |
Long Term Study |
07/03/2007 |
Progress Adequate |
New Enrollment |
07/03/2007 |
Progress Adequate |
P040034
|
COVIDIEN |
DURASEAL DURAL SEALANT SYSTEM |
Neurology |
04/07/2005 |
Duraseal |
04/07/2005 |
Completed |
P080013
|
COVIDIEN |
DURASEAL XACT SEALANT SYSTEM |
Neurology |
09/04/2009 |
DuraSeal Exact Spine Sealant System |
06/29/2010 |
Progress Inadequate |
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 |
P040023
|
DEPUY ORTHOPAEDICS, INC. |
DURALOC OPTION CERAMIC HIP SYSTEM |
Orthopedic |
05/03/2005 |
Prospective Post-Approval Study |
04/20/2010 |
Progress Inadequate |
DePuy Outcomes Tracking System Registry (DOTS) |
04/20/2010 |
Progress Adequate |
Kaiser Permanente Joint Registry |
04/20/2010 |
Progress Adequate |
National Joint Registry for England and Wales |
04/20/2010 |
Progress Adequate |
Australian Orthopedic Assc National Joint Registry |
04/20/2010 |
Progress Adequate |
New England Baptist Hospital Joint Registry |
06/12/2012 |
Progress Adequate |
P090002
|
DEPUY ORTHOPAEDICS, INC. |
PINNACLE COMPLETE ACETABULAR HIP SYSTEM |
Orthopedic |
06/13/2011 |
Pinnacle CoMplete Acetabular Hip System |
11/04/2011 |
Progress Inadequate |
P070026
|
DEPUY, INC. |
CERAMAX CERAMIC HIP SYSTEM |
Orthopedic |
12/23/2010 |
Ceramax PAS |
06/07/2011 |
Progress Inadequate |
P110014
|
DUNE MEDICAL DEVICES INC |
DUNE MEDICAL DEVICES MARGINPROBE SYSTEM |
General & Plastic Surgery |
12/27/2012 |
MarginProbe System US PAS |
|
Protocol Pending |
P110021
|
EDWARDS LIFESCIENCES LLC. |
EDWARDS SAPIEN TRANSCATHETER HEART VALVE |
Cardiovascular |
10/19/2012 |
Continue F/u of Premarket Cohort |
10/19/2012 |
Study Pending |
Newly Enrolled Study |
10/19/2012 |
Study Pending |
P100041
|
EDWARDS LIFESCIENCES, LLC. |
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND RETROFLEX 3 DELIVERY SYSTEM, RETROFLEX BALLOON CATHETER AND CRIMPER |
Cardiovascular |
11/02/2011 |
Continue Follow-Up of Premarket Cohort |
01/31/2012 |
Progress Adequate |
Newly Enrolled Study |
04/06/2012 |
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 |
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 |
Progress Adequate |
P860057
S029
|
EDWARDS LIFESCIENCES, LLC. |
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS MODELS 7000 AND 7000TFX |
Cardiovascular |
08/29/2008 |
Long Term |
12/05/2008 |
Progress Adequate |
P980049
S020
|
ELA MEDICAL, INC. |
OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6250 ICDS, ELAVIEW 1.32 UG2 PROGRAMMING SOFTWARE AND CPR3 PROGRAMMING HEAD |
Cardiovascular |
04/28/2006 |
Ovatio DR6550 Study |
04/28/2006 |
Completed |
H080005
|
ELANA INC. |
ELANA ARTERIOTOMY SYSTEM |
Neurology |
03/10/2011 |
Elana Surgical KitHUD |
03/10/2011 |
Progress Inadequate |
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 Adequate |
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 |
P060001
|
EV3 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 |
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 |
Study Pending |
P030004
|
EV3 NEUROVASCULAR |
ONYX LIQUID EMBOLIC SYSTEM |
Neurology |
07/21/2005 |
Long Term Study |
07/21/2005 |
Completed |
P050039
|
EXACTECH, INC. |
NOVATION CERAMIC ARTICULATION HIP SYSTEM |
Orthopedic |
07/05/2007 |
Novation PAS |
12/09/2010 |
Progress Inadequate |
P080012
|
FLOWONIX MEDICAL, INC. |
PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM |
General Hospital |
02/07/2012 |
Prometra Programmable Pump system |
05/03/2012 |
Study Pending |
Extended Use Stability Study |
05/04/2012 |
Study Pending |
Leachables Study |
05/04/2012 |
Study Pending |
P120007
|
GEN-PROBE INCORPORATED |
APTIMA HPV 16 18/45 GENOTYPE ASSAY |
Microbiology |
10/12/2012 |
HPVGTS-US-10-002 |
10/12/2012 |
Study Pending |
P100042
|
GEN-PROBE INCORPORATED |
APTIMA HPV ASSAY |
Microbiology |
10/28/2011 |
APTIMA HPV Assay |
10/28/2011 |
Progress Adequate |
P080030
|
GLAUKOS, CORPORATION |
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
Ophthalmic |
06/25/2012 |
Extended F/u of IDE Cohort Study |
|
Protocol Pending |
New Enrollment Study |
|
Protocol Pending |
Registry Study |
|
Protocol Pending |
P100003
|
GLOBUS MEDICAL INC. |
SECURE-C ARTIFICIAL CERVICAL DISC |
Orthopedic |
09/28/2012 |
Extended f/u of premarket cohort |
09/28/2012 |
Study Pending |
Enhanced Surveillance |
09/28/2012 |
Study Pending |
P910073
S077
|
GUIDANT CORP. |
ENDOTAK RELIANCE 4-SITE LEADS AND ACCESSORIES |
Cardiovascular |
11/10/2010 |
Longitudinal Surveillance Study |
01/14/2011 |
Study Pending |
P830060
S062
|
GUIDANT CORP. |
LEAD TUNNELER MODEL 6888 |
Cardiovascular |
11/10/2010 |
Longitudinal Surveillance Study |
01/14/2011 |
Terminated |
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 |
P100047
|
HEARTWARE, INC. |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
Cardiovascular |
11/20/2012 |
Newly Enrolled (HW-PAS-01) |
11/20/2012 |
Study Pending |
Training Program (HeartWare-PAS-02) |
11/20/2012 |
Study Pending |
Continued Follow-Up (HW-PAS-03) |
11/20/2012 |
Study Pending |
H090002
|
HOGAN & HARTSON |
HYPERTHERMIA SYSTEM |
Obstetrics/ Gynecology |
11/18/2011 |
Deep Hyperthermia and Radiation |
11/18/2011 |
Progress Inadequate |
P080014
|
HOLOGIC, INC. |
CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT |
Microbiology |
03/12/2009 |
Cervista HPV HR Assay |
03/12/2009 |
Progress Adequate |
P080015
|
HOLOGIC, INC. |
CERVISTA HPV 16/18 |
Microbiology |
03/12/2009 |
Cervista HPV HR Assay |
03/12/2009 |
Progress Adequate |
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 |
P110039
|
INSIGHTEC |
EXABLATE |
General & Plastic Surgery |
10/18/2012 |
New Enrollment Study |
|
Protocol Pending |
Enhanced Surveillance Registry Study |
|
Protocol Pending |
P040003
S006
|
INSIGHTEC, INC. |
EXABLATE 2100 SYSTEM |
Obstetrics/ Gynecology |
12/22/2009 |
Exablate 2100 Type 1.0 |
03/23/2010 |
Progress Adequate |
P040013
S016
|
LUITPOLD PHARMACEUTICALS, INC. |
GEM 21S GROWTH FACTOR ENHANCED MATRIX |
Dental |
05/27/2011 |
GEM21S Growth Factor |
12/06/2011 |
Progress Adequate |
P040024
|
MEDICIS AESTHETICS HOLDINGS,INC. |
RESTYLANE INJECTABLE GEL |
General & Plastic Surgery |
03/25/2005 |
Restylane |
03/25/2005 |
Completed |
P110004
|
MEDINOL LTD. |
PRESILLION PLUS COCR CORONARY STENT RX SYSTEM |
Cardiovascular |
04/12/2012 |
Continued f/u of BLAST Placebo Cohort |
01/24/2012 |
Study Pending |
Enrollment of New US Cohort |
01/24/2012 |
Progress Inadequate |
P060025
|
MEDTRONIC ATS MEDICAL, INC. |
ATS 3F AORTIC BIOPROSTHESIS |
Cardiovascular |
10/30/2008 |
ATS 3f |
08/12/2009 |
Progress Adequate |
P100010
|
MEDTRONIC CRYOCATH LP |
ARCTIC FRONT CRYOCATHETER SYSTEM |
Cardiovascular |
12/17/2010 |
Sustained Treatment of Paroxysmal Atrial Fibrillat |
08/23/2011 |
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 Inadequate |
REVERSE Product Surveillance Registry |
06/29/2012 |
Progress Inadequate |
P060033
|
MEDTRONIC INC. |
ENDEAVOR ZOTAROLIMUS ELUTING CORONARY STENT SYSTEM |
Cardiovascular |
02/01/2008 |
5yr Clinical Outcomes |
02/01/2008 |
Progress Adequate |
Registry PROTECT CA |
09/16/2008 |
Progress Adequate |
Dual Antiplatelet Therapy EDUCATE |
02/01/2008 |
Progress Adequate |
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 |
02/02/2009 |
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
|
MEDTRONIC INC. |
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD |
Cardiovascular |
04/07/2009 |
Elution |
04/07/2009 |
Completed |
Chronic Lead Performance |
02/10/2009 |
Progress Adequate |
P080006
S002
|
MEDTRONIC INC. |
MEDTRONIC ATTAIN ABILITY PLUS MODEL 4296 LEAD |
Cardiovascular |
04/01/2011 |
Chronic Lead Performance |
|
Progress Adequate |
PAPR Straight Lead 4396 |
|
Progress Inadequate |
P080006
S004
|
MEDTRONIC INC. |
MEDTRONIC ATTAIN ABILITY STRAIGHT MODEL 4396 LEFT VENTRICULAR LEAD |
Cardiovascular |
03/31/2011 |
Attain Ability Straight Model 4396 |
|
|
P010031
S176
|
MEDTRONIC INC. |
MEDTRONIC CONSULTA CRT-D D204TRM, MAXIMO II CRT-D D264TRM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS |
Cardiovascular |
01/09/2012 |
Chronic Lead Performance |
01/09/2012 |
Progress Inadequate |
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 Inadequate |
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 Inadequate |
P920015
S055
|
MEDTRONIC INC. |
MEDTRONIC SPRINT QUATTRO SECURE LEAD MODEL 6947M |
Cardiovascular |
01/09/2012 |
Chronic Lead Performance |
01/09/2012 |
Progress Inadequate |
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 |
P980022
S012
|
MEDTRONIC MINIMED |
GUARDIAN RT |
Clinical Chemistry |
08/24/2005 |
PXX/GS041/A |
12/27/2006 |
Completed |
P080025
|
MEDTRONIC NEUROMODULATION |
MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM |
Gastroenterology/ Urology |
03/14/2011 |
FI-PAS |
03/14/2011 |
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 |
P060018
|
MEDTRONIC SOFAMOR DANEK, INC. |
PRESTIGE CERVICAL DISC SYSTEM |
Orthopedic |
07/16/2007 |
Long-Term Study |
07/16/2007 |
Progress Adequate |
Enhanced Surveillance |
07/16/2007 |
Completed |
P040001
|
MEDTRONIC SOFAMOR DANEK, INC. |
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM |
Orthopedic |
11/21/2005 |
LTOS Study |
12/08/2006 |
Progress Adequate |
COAST Study |
12/08/2006 |
Progress Inadequate |
P070027
S011
|
MEDTRONIC VASCULAR |
TALENT ABDOMINAL STENT GRAFT SYSTEM |
Cardiovascular |
02/04/2010 |
Registry |
04/29/2010 |
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 |
09/03/2008 |
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 |
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 |
P100040
|
MEDTRONIC VASCULAR |
VALIANT THORACIC STENT GRAFT SYSTEM |
Cardiovascular |
04/01/2011 |
Captivia Delivery System |
09/14/2011 |
Progress Adequate |
P100021
|
MEDTRONIC VASCULAR |
MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM |
Cardiovascular |
12/16/2010 |
ENGAGE |
05/09/2011 |
Progress Adequate |
P090013
|
MEDTRONIC, INC |
REVO MRI SURESCAN IPG AND PACING SYSTEM |
Cardiovascular |
02/08/2011 |
Chronic Lead Performance/Multiple MRI |
06/10/2011 |
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 |
P090012
|
MELA SCIENCES, INC. |
MELAFIND |
General & Plastic Surgery |
11/01/2011 |
PAS of MelaFind |
08/08/2012 |
Study Pending |
P030053
|
MENTOR CORP. |
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS |
General & Plastic Surgery |
11/17/2006 |
Large PAS |
11/17/2006 |
Progress Inadequate |
Device Failure Study |
11/17/2006 |
Progress Adequate |
Informed Decision Process |
11/17/2006 |
Completed |
Adjunct Study |
11/17/2006 |
Completed |
Core |
11/17/2006 |
Progress Inadequate |
Focus Group |
11/17/2006 |
Completed |
P040047
|
MERZ AESTHETICS, INC. |
COAPTITE |
Gastroenterology/ Urology |
11/10/2005 |
Coaptite |
09/29/2008 |
Progress Adequate |
P050037
|
MERZ AESTHETICS, INC. |
RADIESSE 1.3CC AND 0.3CC |
General & Plastic Surgery |
12/22/2006 |
Radiesse |
12/22/2006 |
Completed |
P050052
|
MERZ AESTHETICS, 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 |
P090016
|
MERZ AESTHETICS, INC. |
BELOTERO BALANCE |
General & Plastic Surgery |
11/14/2011 |
Chemical/Physical Evaluation |
|
Progress Adequate |
Concentration and Molecular Weight |
|
Progress Adequate |
Belotero Balance PAS |
05/01/2012 |
Progress Adequate |
P100018
|
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR |
PIPELINE EMBOLIZATION DEVICE |
Neurology |
04/06/2011 |
Continued Follow-up of Premarket Cohort |
06/27/2011 |
Progress Adequate |
P040025
|
NATUS MEDICAL INCORPORATED |
OLYMPIC COOL-CAP |
Neurology |
12/20/2006 |
VON Registry |
12/20/2006 |
Progress Adequate |
P010047
|
NEOMEND, INC. |
PROGEL PLEURAL AIR LEAK SEALANT |
Anesthesiology |
01/14/2010 |
Long Term Safety |
02/17/2011 |
Progress Adequate |
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 |
H100002
|
NEUROVASX |
CPAX ANEURYSM TREATMENT SYSTEM |
Neurology |
04/01/2011 |
New Enrollment Study |
|
Other |
P000049
S016
|
NMT MEDICAL, INC. |
STARFLEX SEPTAL OCCLUSION SYSTEM |
Cardiovascular |
03/05/2009 |
Fatigue & Corrosion Testing |
03/05/2009 |
Other |
P100034
|
NOVOCURE, LTD. |
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
Neurology |
04/08/2011 |
New Enrollment Study for NovoTTF-100A |
01/03/2012 |
Progress Adequate |
P100012
|
NUVASIVE, INC. |
NUVASIVE PCM CERVICAL DISC SYSTEM |
Orthopedic |
10/26/2012 |
PCM Cervical Enhanced Surveillance |
|
Protocol Pending |
PCM Cervical Long Term |
02/06/2013 |
Study Pending |
P070009
|
OBTECH MEDICAL GMBH |
REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X |
Gastroenterology/ Urology |
09/28/2007 |
Realize PAS |
09/09/2008 |
Progress Adequate |
P110008
|
PARADIGM SPINE, LLC |
COFLEX INTERLAMINAR STABILIZATION DEVICE |
Orthopedic |
10/17/2012 |
Extended f/u of premarket cohort |
|
Protocol Pending |
Coflex Actual Practice PAS |
|
Protocol Pending |
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 |
P070005
|
PATHFINDER CELL THERAPY INC. |
REPEL-CV BIORESORBABLE ADHESION BARRIER |
Cardiovascular |
03/06/2009 |
REPEL CV |
03/06/2009 |
Progress Inadequate |
P100020
|
ROCHE MOLECULAR SYSTEMS, INC. |
COBAS HPV TEST |
Microbiology |
04/19/2011 |
MWP-HPV-159 |
04/19/2011 |
Progress Adequate |
P100014
|
SALIX PHARMACEUTICALS, INC. |
SOLESTA INJECTABLE GEL |
Gastroenterology/ Urology |
05/27/2011 |
Solesta - Long Term Study |
10/27/2011 |
Progress Adequate |
P070004
|
SIENTRA, INC |
SIENTRA SILICONE GEL BREAST IMPLANTS |
General & Plastic Surgery |
03/09/2012 |
Post-Approval PMA Cohorts Study (PACS) |
05/29/2012 |
Progress Adequate |
Post-Approval Continued Access Study (PACAS) |
05/29/2012 |
Progress Adequate |
US Post-Approval Study (US-PAS) |
05/29/2012 |
Study Pending |
Post-Approval Case-Control Studies (PACCS) |
01/11/2012 |
Progress Adequate |
Focus Group Study |
06/07/2012 |
Study Pending |
P050050
|
SMALL BONE INNOVATIONS, INC. |
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE) |
Orthopedic |
05/27/2009 |
Long Term Study |
12/27/2010 |
Progress Inadequate |
Actual Conditions of Use Study |
11/23/2010 |
Progress Inadequate |
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 |
Progress Adequate |
P060027
|
SORIN CRMUSA, INC |
OVATIO CRT SYSTEM |
Cardiovascular |
05/15/2008 |
Long Term |
10/31/2008 |
Other |
P040028
|
SPECTRA SCIENCE |
LUMA CERVICAL IMAGING SYSTEM |
Obstetrics/ Gynecology |
03/16/2006 |
LUMA |
03/16/2006 |
Terminated |
H060002
|
SPIRATION, INC. |
IBV VALVE SYSTEM |
Anesthesiology |
10/24/2008 |
IBV Valve |
11/27/2009 |
Progress Inadequate |
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 |
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
S173
|
ST. JUDE MEDICAL |
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) |
Cardiovascular |
11/29/2011 |
QUAD PAS |
03/02/2012 |
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
S042
|
ST. JUDE MEDICAL, INC. |
RIATA ST OPTIM AND RIATA STS OPTIM |
Cardiovascular |
01/13/2009 |
SJ4 PAS |
05/07/2009 |
Progress Adequate |
P910023
S154
|
ST. JUDE MEDICAL, INC. |
PROMOTE CRT-D SYSTEM |
Cardiovascular |
01/13/2009 |
SJ4 PAS |
09/09/2010 |
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 |
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 |
P030016
|
STAAR SURGICAL CO. |
VISIAN ICL (IMPLANTABLE COLLAMER LENS) |
Ophthalmic |
12/22/2005 |
Adverse Event Study |
12/22/2005 |
Progress Adequate |
Follow-up Study |
12/22/2005 |
Completed |
Axial Lengths |
12/22/2005 |
Completed |
P040051
|
STELKAST COMPANY |
STELKAST SURPASS ACETABULAR SYSTEM |
Orthopedic |
05/12/2006 |
Stelkast Surpass Active PAS |
04/22/2011 |
Progress Adequate |
P020012
|
SUNEVA MEDICAL, INC. |
ARTEFILL |
General & Plastic Surgery |
10/27/2006 |
Study P521-01 |
10/27/2006 |
Progress Adequate |
H100006
|
SYNAPSE BIOMEDICAL |
NEURX DIAPHRAGM PACING SYSTEM (DPS) |
Anesthesiology |
09/28/2011 |
NeuRx DPS |
09/28/2011 |
Progress Inadequate |
P050010
|
SYNTHES SPINE |
PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
Orthopedic |
08/14/2006 |
PRODISC-L Long Term Study |
08/14/2006 |
Progress Adequate |
P070001
|
SYNTHES SPINE |
PRODISC TM-C TOTAL DISC REPLACEMENT |
Orthopedic |
12/17/2007 |
Long Term Study |
08/12/2008 |
Progress Inadequate |
Enhanced Surveillance Study |
08/12/2008 |
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. |
LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS) |
Cardiovascular |
10/07/2008 |
Centrimag PAS |
05/22/2009 |
Progress Inadequate |
P870072
S037
|
THORATEC CORP. |
THORATEC TLC-II PORTABLE VAD DRIVER |
Cardiovascular |
11/14/2007 |
Thoratec TLC-ii portable |
11/14/2007 |
Progress Adequate |
P060040
S005
|
THORATEC CORP. |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
Cardiovascular |
01/20/2010 |
Destination Therapy-INTERMACS |
05/07/2010 |
Progress Adequate |
Heartmate II Bleeding Study |
05/07/2010 |
Completed |
P100049
|
TORAX MEDICAL |
LINX REFLUX MANAGEMENT SYSTEM |
Gastroenterology/ Urology |
03/22/2012 |
Extended f/u of premarket cohort |
06/22/2012 |
Study Pending |
Enrollment Study |
06/22/2012 |
Study Pending |
H100008
|
TRIVASCULAR INC |
OVATION ABDOMINAL STENT SYSTEM |
Cardiovascular |
11/01/2011 |
Ovation Abdomincal Stent Graft System |
11/01/2011 |
Study Pending |
P120006
|
TRIVASCULAR INC |
OVATION ABDOMINAL STENT GRAFT SYSTEM |
Cardiovascular |
10/05/2012 |
Long Term Follow-up Study |
|
Study Pending |
Training Program |
|
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 |
P030050
S002
|
VALEANT INTERNATIONAL (BARBADOS) SRL |
SCULPTRA AESTHETIC |
General & Plastic Surgery |
07/28/2009 |
Pre Clinical PAS |
09/09/2010 |
Completed |
Clinical PAS |
04/05/2011 |
Progress Inadequate |
P060017
|
VERIDEX, LLC |
GENESEARCH BREAST LYMPH NODE(BLN) ASSAY |
Immunology |
07/16/2007 |
PPC Study |
10/29/2007 |
Other |
TS Study |
10/29/2007 |
Other |
P050034
|
VISION CARE OPHTHALMIC TECHNOLOGIES, LTD. |
IMPLANTABLE MINIATURE TELESCOPE (IMT) |
Ophthalmic |
07/01/2010 |
IMT PAS 01 New Enrollment Study |
10/07/2010 |
Study Pending |
Premarket Cohort IMT-002-LTME |
10/13/2010 |
Progress Inadequate |
P930016
S025
|
VISX, INCORPORATED |
STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM |
Ophthalmic |
07/11/2007 |
Star 4 Monovision Lasik |
04/02/2008 |
Other |
P040043
|
W. L. GORE & ASSOCIATES, INC. |
GORE TAG THORACIC ENDOPROSTHESIS |
Cardiovascular |
03/23/2005 |
Cohort Study |
08/31/2005 |
Progress Adequate |
Training Study |
08/31/2005 |
Completed |
P050006
|
W.L. GORE & ASSOCIATES,INC |
GORE HELEX SEPTAL OCCLUDER |
Cardiovascular |
08/11/2006 |
GORE HELEX |
08/11/2006 |
Progress Adequate |
P070016
|
WILLIAM COOK EUROPE APS |
ZENITH TX2 THORACIC TAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM |
Cardiovascular |
05/21/2008 |
Longterm PAS |
11/26/2008 |
Progress Adequate |
P030042
|
WRIGHT MEDICAL TECHNOLOGY, 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 |
P040048
|
ZIMMER, INC. |
TRILOGY AB ACETABULAR SYSTEM |
Orthopedic |
06/28/2006 |
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 |