Post-Approval Study Database Updated with new data fields describing the study Protocol

By Effective Medicine  On  In Medical Devices Tagged  

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
[email protected]

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Application
Number

Applicant
Name

  

Device
Name

Medical
Specialty

Date PMA
Approved

P040038

ABBOTT VASCULAR INC.
XACT CAROTID STENT SYSTEM
Cardiovascular
09/06/2005

PROTECT Study
02/05/2007
Progress Adequate

EXACT Study
10/12/2005
Completed

P070015

ABBOTT VASCULAR INC.
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Cardiovascular
07/02/2008

Longterm IDE Follow up
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
Progress Inadequate

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

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
Progress Adequate

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

PAS
03/27/2009
Progress Adequate

P050033

ANIKA THERAPEUTICS, INC.
ELEVESS
General
Plastic Surgery
12/20/2006

Elevess CTA Study
04/29/2008
Progress Adequate

P070014

BARD PERIPHERAL VASCULAR, INC.
LIFESTENT FLEXSTAR FLEXSTAR XL VASCULAR STENT SYSTEM
Cardiovascular
02/13/2009

CONTINUUM
02/13/2009
Study Pending

RESILIENT
02/13/2009
Completed

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
Protocol Overdue

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
Progress Adequate

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 Inadequate

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
Study Pending

P000040

S014

BOSTON SCIENTIFIC CORP.
GENESYS HTA SYSTEM
Obstetrics/
Gynecology
04/23/2010

Genesys HTA Post Approval Registry
07/16/2010
Study Pending

P050025

BOSTON SCIENTIFIC CORP.
ENDOTEX NEXSTENT CAROTID STENT AND DELIVERY SYSTEM AND ENDOTEX CAROTID STENT AND MONORAIL DELIVERY SYSTEM
Cardiovascular
10/27/2006

CABERNET Registry
10/12/2006
Completed

SONOMA
10/12/2006
Other

P050019

BOSTON SCIENTIFIC CORP.
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS
Cardiovascular
10/23/2008

CABANA REGISTRY
10/23/2008
Progress Adequate

BEACH STUDY
10/23/2008
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

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
Progress Adequate

TAXUS Registry
10/10/2008
Progress Adequate

Dual Antiplatelet Study
08/28/2010
Progress Adequate

Fatigue Stability Testing
10/10/2008
Progress Adequate

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
Progress Adequate

Fatigue/Matter Testing
09/24/2008
Completed

P060008

S011

BOSTON SCIENTIFIC CORPORATION
TAXUS LIBERTE’ PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Cardiovascular
07/13/2009

TAXUS Long (S011)
07/23/2010
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
Progress Adequate

P010012

S230

BOSTON SCIENTIFIC CORPORATION (BSC)
BOSTON SCIENTIFIC CARDIAC RESYNCHRONIZATION THERPY DEFIBRILLATORS (CRT-DS)
Cardiovascular
09/16/2010

MADIT-CRT ACC NCDR
09/15/2010
Study Pending

MADIT-CRT Registry
09/15/2010
Study Pending

P040016

BOSTON SCIENTIFIC SCIMED, INC.
LIBERTE MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS
Cardiovascular
04/12/2005

Longterm Outcomes
04/12/2005
Completed

P060002

C.R. BARD, INC.
FLAIR ENDOVASCULAR STENT GRAFT
Cardiovascular
07/23/2007

FLAIR Endovascular Grafts
03/13/2008
Progress Adequate

P970051

S028

COCHLEAR AMERICAS
NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
Ear Nose Throat
03/01/2005

Pediatric Study
03/01/2005
Completed

Adult Study
03/01/2005
Completed

P070013

COLBAR LIFESCIENCE LTD.
EVOLENCE COLLAGEN FILLER
General
Plastic Surgery
06/27/2008

EVOLENCE
09/15/2008
Progress Inadequate

P020014

S012

CONCEPTUS, INC.
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL
Obstetrics/
Gynecology
06/15/2007

ESS-305
06/15/2007
Completed

P040034

CONFLUENT SURGICAL,INC
DURASEAL DURAL SEALANT SYSTEM
Neurology
04/07/2005

Duraseal
04/07/2005
Completed

P020018

S005

COOK, INC.
ZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE HLB ONE-SHOT INTRODUCTION SYSTEM
Cardiovascular
06/09/2005

Postmarket Surveillance Registry
06/09/2005
Progress Adequate

P020018

S010

COOK, INC.
36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT
Cardiovascular
09/07/2006

AAA Flex 36mm
09/07/2006
Progress Inadequate

P030047

CORDIS CORP.
CORDIS PRECISE NITINOL STENT SYSTEM
Cardiovascular
09/22/2006

Longterm CASES Studies
09/22/2006
Completed

P020026

S017

CORDIS CORPORATION
RAPTORRAIL RX SDS, 2.25MM CYPHER STENT
Cardiovascular
09/18/2009

CYPHER MINI
08/17/2009
Study Pending

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 Inadequate

P080013

COVIDIEN
DURASEAL XACT SEALANT SYSTEM
Neurology
09/04/2009

DuraSeal Spine Sealant PAS
06/29/2010
Study Pending

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
Progress Adequate

P040023

DEPUY ORTHOPAEDICS, INC.
DURALOC OPTION CERAMIC HIP SYSTEM
Orthopedic
05/03/2005

Duraloc Long Term
05/03/2005
Other

Prospective Post-Approval Study
04/20/2010
Study Pending

DePuy Outcomes Tracking System Registry
04/20/2010
Study Pending

Kaiser Permanente Joint Registry
04/20/2010
Study Pending

National Joint Registry for England and Wales
04/20/2010
Study Pending

Australian Orthopedic Assc National Joint Registry
04/20/2010
Study Pending

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

P860057

S042

EDWARDS LIFESCIENCES, LLC.
CAPENTIER EDWARDS PERIMOUNT MAGNA EASE PERICARDIAL AORTIC BIOPROSTHESIS
Cardiovascular
05/07/2009

Clinical Study
11/03/2009
Progress Adequate

P060027

ELA MEDICAL, INC.
OVATIO CRT SYSTEM
Cardiovascular
05/15/2008

Long Term
10/31/2008
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
Progress Adequate

P090018

ENVOY MEDICAL CORPORATION
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM
Ear Nose Throat
03/17/2010

Extended Follow-up of PMA study
08/16/2010
Study Pending

New Enrollment
08/16/2010
Study Pending

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
Progress Adequate

CREATE (IDE)
08/02/2007
Completed

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

Long Term
07/05/2007
Study Pending

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 Adequate

P080014

HOLOGIC, INC.
CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT
Microbiology
03/12/2009

Follow up Study
03/12/2009
Progress Adequate

P080015

HOLOGIC, INC.
CERVISTA HPV 16/18
Microbiology
03/12/2009

Follow up PAS
03/12/2009
Progress Adequate

P070022

HOLOGIC, INC.
ADIANA PERMANENT CONTRACEPTION SYSTEM
Obstetrics/
Gynecology
07/06/2009

EASE TRIAL
07/06/2009
Progress Inadequate

P040052

HOLOGIC, INC.
MONOPREP PAP TEST
Pathology
03/03/2006

CHOICE Study
12/18/2007
Other

SURE Study
10/18/2007
Completed

P040003

S006

INSIGHTEC, INC.
EXABLATE 2100 SYSTEM
Obstetrics/
Gynecology
12/22/2009

Exablate 2100
03/23/2010
Study Pending

H070004

LEVITRONIX LLC.
LEVITRONIX CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)
Cardiovascular
10/07/2008

Centrimag PAS
05/22/2009
Progress Adequate

P040024

MEDICIS AESTHETICS HOLDINGS,INC.
RESTYLANE INJECTABLE GEL
General
Plastic Surgery
03/25/2005

Restylane
03/25/2005
Completed

P060039

MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
ATTAIN STARFIX MODEL 4195 LEAD
Cardiovascular
06/13/2008

Chronic Extraction
02/02/2009
Progress Adequate

Chronic Performance Study
02/02/2009
Progress Adequate

P980035

S073

MEDTRONIC INC.
MEDTRONIC ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATOR AND MODEL SW003 APPLICATION SOFTWARE
Cardiovascular
05/13/2008

Longterm Study PAS
08/11/2008
Progress Adequate

P890003

S119

MEDTRONIC INC.
CARELINK MONITOR MODEL 2490H
Cardiovascular
05/13/2008

Longterm PAS

Progress Adequate

P010031

S104

MEDTRONIC INC.
CONCERTO/INSYNC SENTRY/INSYNC MAXIMO
Cardiovascular
08/28/2008

Enhanced Surveillance
08/28/2008
Progress Adequate

P980016

S135

MEDTRONIC INC.
VIRTUOSO DR/VR/ENTRUST DR/VR/MAXIMO DR/VR/INTRINSIC DR
Cardiovascular
08/28/2008

Enhanced Surveillance
08/28/2008
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 Inadequate

P060025

MEDTRONIC INC.
ATS 3F AORTIC BIOPROSTHESIS
Cardiovascular
10/30/2008

ATS 3f
08/12/2009
Progress Inadequate

P060033

MEDTRONIC IRELAND
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

P980022

S012

MEDTRONIC MINIMED
GUARDIAN RT
Clinical Chemistry
08/24/2005

PXX/GS041/A
12/27/2006
Completed

P060023

MEDTRONIC SOFAMOR DANEK USA, INC.
BRYAN CERVICAL DISC PROSTHESIS
Orthopedic
05/12/2009

Long-Term Study
05/12/2009
Progress Inadequate

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 Inadequate

Enhanced Surveillance
07/16/2007
Progress Adequate

P040001

MEDTRONIC SPINE LLC.
X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM
Orthopedic
11/21/2005

LTOS Study
12/08/2006
Progress Adequate

COAST Study
12/08/2006
Progress Inadequate

P070007

MEDTRONIC VASCULAR
TALENT THORACIC STENT GRAFT SYSTEM
Cardiovascular
06/05/2008

THRIVE Trial
09/03/2008
Progress Inadequate

P070012

MEDTRONIC VASCULAR
EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
Cardiovascular
10/23/2007

MAVErIC II Long Term Study
10/23/2007
Completed

EMERGE
10/23/2007
Terminated

P070027

MEDTRONIC VASCULAR
THE TALENT ABDOMINAL STENT GRAFT SYSTEM
Cardiovascular
04/15/2008

Vitality Trial
11/05/2008
Progress Adequate

P070027

S011

MEDTRONIC VASCULAR
TALENT ABDOMINAL STENT GRAFT SYSTEM
Cardiovascular
02/04/2010

Registry
04/29/2010
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
Study Pending

Generalizability Study
04/06/2010
Progress Adequate

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
Progress Adequate

Adjunct Study
11/17/2006
Progress Inadequate

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

P050052

MERZ AESTHETICS, INC.
RADIESSE 1.3CC AND 0.3CC
General
Plastic Surgery
12/22/2006

Long Term (Nasolabial Folds)
12/22/2006
Completed

Short Term (Fitzpatrick)
12/22/2006
Completed

P050037

MERZ AESTHETICS, INC.
RADIESSE 1.3CC AND 0.3CC
General
Plastic Surgery
12/22/2006

Radiesse
12/22/2006
Completed

P010047

NEOMEND, INC.
PROGEL PLEURAL AIR LEAK SEALANT
General
Plastic Surgery
01/14/2010

Long Term Safety

Protocol Pending

P000049

S016

NMT MEDICAL, INC.
STARFLEX SEPTAL OCCLUSION SYSTEM
Cardiovascular
03/05/2009

Fatigue Corrosion Testing
03/05/2009
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

P040025

OLYMPIC MEDICAL CORP.
OLYMPIC COOL-CAP
Neurology
12/20/2006

VON Registry
12/20/2006
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
Progress Adequate

P030050

S002

SANOFI AVENTIS U.S. LLC
SCULPTRA AESTHETIC
General
Plastic Surgery
07/28/2009

Pre Clinical PAS
09/09/2010
Progress Adequate

Clinical PAS

Protocol Overdue

P050050

SMALL BONE INNOVATIONS, INC.
SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (S.T.A.R.ANKLE)
Orthopedic
05/27/2009

Long Term Study

Protocol Overdue

Actual Conditions of Use Study
11/23/2010
Study Pending

P040033

SMITHNEPHEW ORTHOPAEDICS
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
Orthopedic
05/09/2006

US Study
05/09/2006
Progress Adequate

UK Study
05/09/2006
Progress Adequate

P040028

SPECTRA SCIENCE
LUMA CERVICAL IMAGING SYSTEM
Obstetrics/
Gynecology
03/16/2006

LUMA
03/16/2006
Progress Inadequate

H060002

SPIRATION, INC.
IBV VALVE SYSTEM
Anesthesiology
10/24/2008

IBV Valve
11/27/2009
Study Pending

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

PAS

Progress Adequate

P950022

S042

ST. JUDE MEDICAL, INC.
RIATA ST OPTIM AND RIATA STS OPTIM
Cardiovascular
01/13/2009

Long Term
05/07/2009
Progress Adequate

P910023

S154

ST. JUDE MEDICAL, INC.
PROMOTE CRT-D SYSTEM
Cardiovascular
01/13/2009

Long Term
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 Inadequate

P030016

STAAR SURGICAL CO.
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
Ophthalmic
12/22/2005

Adverse Event Study
12/22/2005
Progress Inadequate

Follow-up Study
12/22/2005
Progress Inadequate

Axial Lengths
12/22/2005
Progress Adequate

P040051

STELKAST COMPANY
STELKAST SURPASS ACETABULAR SYSTEM
Orthopedic
05/12/2006

Long term
05/12/2006
Protocol Overdue

P020012

SUNEVA MEDICAL, INC.
ARTEFILL
General
Plastic Surgery
10/27/2006

Study P521-01
10/27/2006
Progress Adequate

P070005

SYNTHEMED CORP.
REPEL-CV BIORESORBABLE ADHESION BARRIER
Cardiovascular
03/06/2009

REPEL CV
03/06/2009
Progress Inadequate

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

P050010

SYNTHES SPINE
PRODISC -L TOTAL DISC REPLACEMENT DEVICE
Orthopedic
08/14/2006

PRODISC-L Long Term Study
08/14/2006
Progress Inadequate

P060040

THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Cardiovascular
04/21/2008

INTERMACS Registry
04/21/2008
Progress Adequate

P870072

S037

THORATEC CORP.
THORATEC TLC-II PORTABLE VAD DRIVER
Cardiovascular
11/14/2007

Thoratec TLC-ii portable
11/14/2007
Progress Adequate

P060040

S005

THORATEC CORP.
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
Cardiovascular
01/20/2010

INTERMACS
05/07/2010
Progress Adequate

Heartmate II Bleeding Study
05/07/2010
Progress Adequate

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

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
10/07/2010
Study Pending

Premarket Cohort IMT-002-LTME
10/13/2010
Study Pending

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 HLB 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

Long-Term Study
07/16/2010
Study Pending

New Enrollment Study
06/21/2010
Study Pending

P040048

ZIMMER, INC.
TRILOGY AB ACETABULAR SYSTEM
Orthopedic
06/28/2006

PAS002
06/04/2010
Study Pending

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

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