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