|
|
Application Number |
|
|
|
Application |
|
|
|
Device Name |
|
|
|
|
Date PMA Approved |
|
|
|
|
|
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 |
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 |
P980040
S065
|
ABBOTT MEDICAL OPTICS INC |
TECNIS SYMFONY EXTENDED RANGE OF VISION INTRAOCULAR LENS |
Ophthalmic |
07/15/2016 |
OSB Lead-TECNIS Symfony Toric New Enrollment Study
|
|
Protocol Pending |
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 |
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 |
P150023
|
ABBOTT VASCULAR INC. |
ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEM |
Cardiovascular |
07/05/2016 |
ODE Lead ABSORB IV Post-Approval Study
|
|
Study Pending |
OSB Lead-ABSORB USA Post Approval Clinical Study
|
|
Protocol Pending |
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 |
P140003
S004
|
ABIOMED, INC. |
IMPELLA VENTRICULAR SUPPORT SYSTEMS |
Cardiovascular |
04/07/2016 |
OSB Lead-Impella AMI CS PAS
|
08/09/2016 |
Progress Adequate |
P140003
S005
|
ABIOMED, INC. |
IMPELLA LEFT VENTRICULAR SUPPORT SYSTEM |
Cardiovascular |
04/07/2016 |
OSB Lead-Impella PCCS PAS
|
08/09/2016 |
Progress Adequate |
P140003
|
ABIOMED, INC. |
IMPELLA |
Cardiovascular |
03/23/2015 |
OSB Lead-New Enrollment Study
|
|
Progress Adequate |
H140001
|
ABIOMED, INC. |
IMPELLA RP SYSTEM |
Cardiovascular |
01/23/2015 |
OSB Lead-Impella RP Pediatric Study
|
01/23/2015 |
Progress Adequate |
OSB Lead-Impella RP Prospective Study
|
01/23/2015 |
Progress Adequate |
P120023
|
ACUFOCUS, INC. |
KAMRA INLAY |
Ophthalmic |
04/17/2015 |
OSB Lead-New Enrollment Study
|
05/12/2016 |
Study Pending |
ODE Lead PAS-Continuation Study
|
|
Progress Adequate |
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 |
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 |
P150037
|
Alcon Research, Ltd |
CyPass Micro-Stent |
Ophthalmic |
07/29/2016 |
ODE Lead-COMPASS Extenstion Study
|
|
Study Pending |
OSB Lead-Cypass Micro Stent New Enrollment PAS
|
|
Protocol Pending |
P020056
|
Allergan |
NATRELLE SILICONE-FILLED BREAST IMPLANTS |
General & Plastic Surgery |
11/17/2006 |
OSB Lead-Re-Op Phase
|
01/16/2015 |
Progress Adequate |
OSB Lead-BIFS (Large PAS)
|
08/03/2015 |
Progress Inadequate |
OSB Lead-Natrelle and 410 Combined Cohort
|
08/25/2016 |
Progress Adequate |
P040046
|
Allergan |
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS |
General & Plastic Surgery |
02/20/2013 |
OSB Lead-Natrelle and 410 Combined Cohort
|
08/25/2016 |
Progress Adequate |
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 |
P000008
S017
|
APOLLO ENDOSURGERY INC |
LAP-BAND |
Gastroenterology/ Urology |
02/16/2011 |
OSB Lead-Apollo-001
|
03/03/2016 |
Progress Inadequate |
P140008
|
APOLLO ENDOSURGERY INC |
ORBERA INTRAGASTRIC BALLOON |
Gastroenterology/ Urology |
08/05/2015 |
OSB Lead-ORBERA PAS (OPAS-001)
|
02/26/2016 |
Progress Adequate |
P150024
|
ASPIRE BARIATRICS INC |
AspireAssist |
Gastroenterology/ Urology |
06/14/2016 |
ODE Lead-PATHWAY Clinical Trial PAS
|
|
Study Pending |
OSB Lead-AspireAssist Post-Approval Study
|
12/15/2016 |
Study Pending |
P100046
|
ATRICURE INC. |
ATRICURE SYNERGY ABLATION SYSTEM |
Cardiovascular |
12/14/2011 |
OSB Lead-AtriCure Synergy Ablation System
|
06/13/2014 |
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 |
P070014
S037
|
BARD PERIPHERAL VASCULAR, INC. |
BARD LIFESTENT VASCULAR STENT SYSTEM |
Cardiovascular |
05/31/2016 |
OSB Lead-Popliteal Indication PAS Surv Project
|
|
Study Pending |
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 |
P070014
|
BARD PERIPHERAL VASCULAR, INC. |
LIFESTENT FLEXSTAR & FLEXSTAR XL VASCULAR STENT SYSTEM |
Cardiovascular |
02/13/2009 |
OSB Lead-CONTINUUM
|
07/11/2014 |
Progress Adequate |
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 |
P020014
S017
|
BAYER PHARMA AG |
CONCEPTUS ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL |
Obstetrics/ Gynecology |
02/24/2012 |
OSB Lead-Essure/post-NovaSure PAS
|
09/29/2016 |
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 |
H100004
|
Berlin Heart Inc. |
EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICE |
Cardiovascular |
12/16/2011 |
OSB Lead-All Comers Registry
|
07/27/2012 |
Progress Adequate |
P000018
|
BEST VASCULAR, INC |
BETA-CATH (TM) SYSTEM |
Cardiovascular |
11/03/2000 |
OSB Lead-Beta-Cath Long Term
|
02/23/2011 |
Progress Inadequate |
P010014
|
BIOMET MANUFACTURING CORP. |
OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM |
Orthopedic |
04/21/2004 |
OSB Lead-Long Term PAS
|
01/04/2013 |
Progress Adequate |
P100006
|
BIOMIMETIC THERAPEUTICS,LLC |
AUGMENT BONE GRAFT |
Orthopedic |
09/01/2015 |
ODE Lead-Extended f/u of Premarket Cohort
|
03/18/2016 |
Progress Adequate |
P030031
S011
|
BIOSENSE WEBSTER, INC. |
NAVISTAR & CELSIUS THERMOCOOL CATHETERS |
Cardiovascular |
02/06/2009 |
OSB Lead-Atrial Fibrillation Registry
|
09/23/2011 |
Progress Adequate |
OSB Lead-CABANA Trial
|
11/24/2009 |
Progress Adequate |
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 |
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 |
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
|
|
Progress Adequate |
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
|
|
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 |
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 |
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 |
P080032
|
Boston Scientific Corp. |
ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
Anesthesiology |
04/27/2010 |
OSB Lead-New Patient Study
|
09/14/2010 |
Progress Adequate |
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 |
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 |
P060008
|
Boston Scientific Corp. |
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) |
Cardiovascular |
10/10/2008 |
OSB Lead-Fatigue & Stability Testing
|
10/10/2008 |
Progress Adequate |
P110010
S001
|
Boston Scientific Corp. |
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Cardiovascular |
06/01/2012 |
OSB Lead-PROMUS Element Plus US PAS
|
08/24/2012 |
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 |
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)
|
11/30/2016 |
Revised/Replaced Study |
OSB Lead-WATCHMAN Comprehensive/Linked-Registry
|
11/30/2016 |
Progress Adequate |
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
|
|
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 |
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 |
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 |
P150012
|
BOSTONSCIENTIFIC |
IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
Cardiovascular |
04/25/2016 |
ODE Lead-INGEVITY and SAMURAI
|
|
Progress Adequate |
P150026
|
CARDIOFOCUS, INC. |
HEARTLIGHT ENDOSCOPIC ABLATION SYSTEM |
Cardiovascular |
04/01/2016 |
OSB Lead-PAS of HeartLight Endoscopic Ablation Sys
|
|
Progress Adequate |
P150017
|
Cartiva, Inc |
CARTIVA SYNTHETIC CARTILAGE IMPLANT |
Orthopedic |
07/01/2016 |
ODE Lead MOTION Extend Study
|
|
Study Pending |
P140019
|
CERAPEDICS, LLC |
I-FACTOR PEPTIDE ENHANCED BONE GRAFT |
Orthopedic |
11/03/2015 |
ODE Lead-Post-Approval Study
|
|
Progress Adequate |
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 Adequate |
P890055
S026
|
CODMAN |
CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP |
General Hospital |
12/17/2010 |
OSB Lead-Leachables Study
|
03/15/2011 |
Progress Adequate |
OSB Lead-Drug Stability Study
|
03/15/2011 |
Progress Adequate |
P100022
|
COOK MEDICAL INCORPORATED |
ZILVER PTX DRUG-ELUTING PERIPHERAL STENT |
Cardiovascular |
11/14/2012 |
OSB Lead-Zilver PTX Stent PAS
|
01/13/2015 |
Progress Inadequate |
OSB Lead-New US Enrollment
|
02/15/2013 |
Progress Adequate |
P140016
|
COOK MEDICAL INCORPORATED |
ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT |
Cardiovascular |
09/15/2015 |
ODE Lead-Post-Approval Study
|
|
Progress Adequate |
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 |
P050016
|
CORIN U.S.A. |
CORMET HIP RESURFACING SYSTEM |
Orthopedic |
07/03/2007 |
OSB Lead-Long Term Study
|
11/04/2008 |
Progress Adequate |
P040023
|
DEPUY ORTHOPAEDICS, INC. |
DURALOC OPTION CERAMIC HIP SYSTEM |
Orthopedic |
05/03/2005 |
OSB Lead-Duraloc Long Term
|
05/03/2005 |
Revised/Replaced Study |
P070026
|
DEPUY ORTHOPAEDICS, INC. |
CERAMAX CERAMIC HIP SYSTEM |
Orthopedic |
12/23/2010 |
OSB Lead-Ceramax PAS
|
03/18/2015 |
Progress Inadequate |
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 |
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 |
P110021
|
EDWARDS LIFESCIENCES LLC. |
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
10/19/2012 |
OSB Lead-Newly Enrolled Study
|
09/13/2013 |
Progress Adequate |
P100041
|
EDWARDS LIFESCIENCES, LLC. |
EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
11/02/2011 |
OSB Lead-Newly Enrolled Study
|
08/28/2014 |
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)
|
08/02/2016 |
Progress Adequate |
OSB Lead-Comprehensive/Linked-Registry Based Surv
|
06/16/2014 |
Progress Adequate |
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 |
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 |
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
|
08/19/2016 |
Progress Adequate |
OSB Lead-Comprehensive Linked Registry-Based Surv
|
|
Progress Adequate |
P130009
S037
|
EDWARDS LIFESCIENCES, LLC. |
SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
02/29/2016 |
ODE Lead-COMPASSION Cohort
|
|
Progress Adequate |
OSB Lead-New Enrollment SAPIEN XT Pulmonic PAS
|
09/20/2016 |
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
|
08/19/2016 |
Progress Adequate |
OSB Lead-Comprehensive/Linked-Registry
|
|
Study Pending |
P140031
S010
|
EDWARDS LIFESCIENCES, LLC. |
SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
08/18/2016 |
ODE Lead-Continued f/u of premarket cohort
|
|
Study Pending |
OSB Lead-Novel Surveillance
|
|
Study Pending |
P130009
S057
|
EDWARDS LIFESCIENCES, LLC. |
EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES |
Cardiovascular |
08/18/2016 |
ODE Lead-Continued f/u of premarket cohort
|
|
Study Pending |
OSB Lead-Novel Surveillance
|
|
Study Pending |
P130019
|
ENTEROMEDICS INC. |
MAESTRO RECHARGEABLE SYSTEM |
Gastroenterology/ Urology |
01/14/2015 |
ODE Lead-Extended F/u of Premarket Cohort
|
06/27/2016 |
Progress Adequate |
OSB Lead-New Enrollment Study
|
|
Progress Inadequate |
P090018
|
ENVOY MEDICAL CORPORATION |
ESTEEM TOTALLY IMPLANTABLE HEARING SYSTEM |
Ear Nose & Throat |
03/17/2010 |
OSB Lead-New Enrollment
|
03/18/2016 |
Revised/Replaced Study |
OSB Lead-Esteem New Enrollment 2
|
03/18/2016 |
Progress Adequate |
P130001
|
EPIGENOMICS AG |
Epi proColon |
Pathology |
04/12/2016 |
OSB Lead-Epi proColon PAS
|
|
Study Pending |
P130017
|
Exact Sciences Corporation |
COLOGUARD |
Pathology |
08/11/2014 |
OSB Lead-Cologuard PAS
|
09/25/2015 |
Progress Adequate |
P050039
|
EXACTECH, INC. |
NOVATION CERAMIC ARTICULATION HIP SYSTEM |
Orthopedic |
07/05/2007 |
OSB Lead-Novation PAS
|
12/09/2010 |
Progress Adequate |
OSB Lead-Long Term
|
12/09/2010 |
Revised/Replaced Study |
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 |
P080030
|
GLAUKOS, CORPORATION |
GLAUKOS ISTENT TRABECULAR BYPASS STENT MODEL GTS100R/L |
Ophthalmic |
06/25/2012 |
OSB Lead-New Enrollment Study
|
05/13/2016 |
Progress Adequate |
OSB Lead-Registry Study
|
07/21/2015 |
Revised/Replaced Study |
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 |
P950039
S026
|
HOLOGIC, INC. |
THINPREP-5000 |
Pathology |
03/02/2015 |
OIR Lead-Post-Approval Study
|
|
Progress Adequate |
P010013
S041
|
HOLOGIC, INC. |
NOVASURE IMPENDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM |
Obstetrics/ Gynecology |
02/01/2013 |
OSB Lead-NovaSure PAS
|
06/15/2015 |
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 |
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 Inadequate |
P150038
|
InSightec |
EXABLATE |
Neurology |
07/11/2016 |
ODE Lead-Long Term PAS
|
|
Study Pending |
P040003
S015
|
INSIGHTEC, LTD |
EXABLATE |
Obstetrics/ Gynecology |
08/31/2015 |
OSB Lead-Post ExAblate Pregnancy Outcomes Registry
|
|
Progress Adequate |
P040003
S016
|
INSIGHTEC, LTD |
EXABLATE |
Obstetrics/ Gynecology |
10/05/2015 |
ODE Lead-Study to Evaluate Safety of ExAblate
|
|
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 |
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 |
P000057
|
INTEGRA LIFESCIENCES CORPORATION |
ASCENSION MCP |
Orthopedic |
11/19/2001 |
OSB Lead-Ascension MCPT
|
02/08/2002 |
Progress Inadequate |
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 Inadequate |
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 Inadequate |
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 |
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 |
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 |
P110032
|
LOMBARD MEDICAL TECHNOLOGIES INC |
AORFIX FLEXIBLE STENT GRAFT SYSTEM |
Cardiovascular |
02/14/2013 |
OSB Lead-Comprehensive/Linked-Registry Based Surv
|
|
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)
|
10/14/2016 |
Progress Adequate |
P000025
S084
|
MED-EL CORP. |
MED-EL COCHLEAR IMPLANT SYSTEM |
Ear Nose & Throat |
09/15/2016 |
ODE Lead-MED-EL EAS Extended f/u Study
|
|
Protocol Pending |
P030006
|
MEDIFOCUS, INC |
PROLIEVE THERMODILATATION SYSTEM |
Gastroenterology/ Urology |
02/19/2004 |
OSB Lead-Prolieve PAS
|
03/11/2005 |
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 |
P100047
|
Medtronic |
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 |
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 |
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 |
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 |
P930039
S142
|
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
CAPSUREFIX NOVUS MRI SURESCAN LEAD MODEL 5076 |
Cardiovascular |
04/28/2016 |
OSB Lead-Post-Approval Study
|
|
Progress Adequate |
P010031
S513
|
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
AMPLIA MRI/AMPLIA MRI QUAD CRT-D SURESCAN; COMPIA MRI/COMPIA MRI QUAD CRT-D SURESCAN |
Cardiovascular |
02/01/2016 |
OSB LeadMR conditional Tachy Therapy Systems Study
|
|
Progress Adequate |
P930039
S140
|
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
CAPSUREFIX NOVUS MRI SURESCAN |
Cardiovascular |
02/01/2016 |
OSB Lead-MR conditional Tachy Therapy Systems
|
|
Progress Adequate |
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
|
|
Progress Adequate |
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 |
P980016
S536
|
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT |
EVERA MRI XT DR, XT VR, S DR, S VR SURESCAN ICD'S |
Cardiovascular |
09/11/2015 |
OSB Lead-MR conditional Tachy Therapy Systems
|
|
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 |
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 |
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 |
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 |
P100010
|
Medtronic CryoCath LP |
ARCTIC FRONT CRYOCATHETER SYSTEM |
Cardiovascular |
12/17/2010 |
OSB Lead-STOP AF PAS
|
08/31/2016 |
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 |
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 |
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 |
P060039
|
MEDTRONIC Inc. |
ATTAIN STARFIX MODEL 4195 LEAD |
Cardiovascular |
06/13/2008 |
OSB Lead-Chronic Performance Study
|
11/19/2013 |
Progress Adequate |
P080006
|
MEDTRONIC Inc. |
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD |
Cardiovascular |
04/07/2009 |
OSB Lead-Chronic Lead Performance
|
12/05/2013 |
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 |
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 |
P980035
S442
|
MEDTRONIC Inc. |
ADVISA MRI DR/SR SURESCAN IPGS AND PROGRAMMER SOFTWARE |
Cardiovascular |
04/28/2016 |
OSB Lead-Post-Approval Study
|
|
Progress Adequate |
P920015
S166
|
MEDTRONIC Inc. |
SPRINT QUATTRO SECURE S MRI SURESCAN LEAD MODEL 6935M,SPRINT QUATTRO SECURE MRI SURESCAN LEAD MODEL 6947M |
Cardiovascular |
04/28/2016 |
OSB Lead-Post-Approval Study
|
|
Progress Adequate |
P080006
S085
|
MEDTRONIC Inc. |
ATTAIN ABILITY MRI , PLUS MRI,STRAIGHT MRI SURESCAN; ATTAIN PERFORMA MRI, STRAIGHT ANS S MRI SURESCAN |
Cardiovascular |
02/01/2016 |
OSB Lead-MR conditional Tachy Therapy Systems
|
|
Progress Adequate |
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
|
|
Progress Adequate |
P140010
S015
|
MEDTRONIC Inc. |
IN PACT ADMIRAL PACLITAXEL-ELUTING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER |
Cardiovascular |
09/07/2016 |
OSB Lead-Surveillance Post Market Registry
|
|
Study Pending |
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 |
P920015
S151
|
MEDTRONIC Inc. |
SPRINT QUATTRO SECURE S MRI SURESCAN AND SPRINT QUATTRO SECURE MRI SURESCAN |
Cardiovascular |
09/11/2015 |
OSB Lead-MR conditional Tachy Therapy Systems
|
|
Progress Adequate |
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 |
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 |
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 |
P160017
|
MEDTRONIC MINIMED |
MiniMed 670G System |
Clinical Chemistry |
09/28/2016 |
OIR Lead-Post Approval Study
|
|
Protocol Pending |
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 |
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 |
P090029
|
Medtronic Sofamor Danek USA, Inc. |
PRESTIGE LP CERVICAL DISC |
Orthopedic |
07/24/2014 |
OSB Lead-Extended Follow-Up
|
07/24/2014 |
Progress Inadequate |
OSB Lead-Enhanced Surveillance Study
|
04/06/2015 |
Progress Adequate |
OSB Lead-Device Failure
|
03/11/2016 |
Progress Adequate |
P090029
S003
|
Medtronic Sofamor Danek USA, Inc. |
PRESTIGE LP(TM) CERVICAL DISC |
Orthopedic |
07/07/2016 |
ODE Lead-10 Year Extended f/u of IDE Subjects
|
|
Study Pending |
OSB Lead-PRESTIGE LP 2-Level Metal Concentrations
|
|
Study Pending |
P100021
|
Medtronic Vascular |
MEDTRONIC VASCULAR ENDURANT STENT GRAFT SYSTEM |
Cardiovascular |
12/16/2010 |
OSB Lead-ENGAGE
|
01/24/2014 |
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 |
P100040
S012
|
Medtronic Vascular |
VALIANT THORACIC STENT GRAFT WITH CAPTIVIA DELIVERY SYSTEM |
Cardiovascular |
01/22/2014 |
OSB Lead-Comprehensive/Linked-Registry Based Surv.
|
|
Progress Adequate |
P110023
|
MEDTRONIC VASCULAR INC |
EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX) |
Cardiovascular |
03/07/2012 |
OSB Lead-Durability II PAS
|
11/23/2016 |
Progress Adequate |
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 |
P090013
S205
|
Medtronic, Inc |
CAPSUREFIX MRI SURESCAN LEAD MODEL 5086MRI |
Cardiovascular |
04/28/2016 |
OSB Lead-Post-Aproval Study
|
|
Progress Adequate |
P090013
S202
|
Medtronic, Inc |
CAPSUREFIX MRI SURESCAN |
Cardiovascular |
02/01/2016 |
OSB Lead-MR conditional Tachy Therapy Systems
|
|
Progress Adequate |
P030053
|
MENTOR CORP. |
MEMORYGEL SILICONE GEL -FILLED BREAST IMPLANTS |
General & Plastic Surgery |
11/17/2006 |
OSB Lead-Re-Op Phase
|
01/16/2015 |
Progress Adequate |
OSB Lead-Large PAS
|
10/01/2014 |
Revised/Replaced Study |
OSB Lead-MemoryGel and Shape Glow Study
|
02/12/2016 |
Progress Adequate |
P060028
|
MENTOR WORLDWIDE LLC |
MENTOR MEMORYSHAPE BREAST IMPLANTS |
General & Plastic Surgery |
06/14/2013 |
OSB Lead-MemoryGel and Shape Glow Study
|
02/12/2016 |
Progress Adequate |
P040047
|
MERZ NORTH AMERICA, INC |
COAPTITE |
Gastroenterology/ Urology |
11/10/2005 |
OSB Lead-Coaptite
|
09/29/2008 |
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 |
Progress Adequate |
OSB Lead-Radiesse New Enrollment Study
|
|
Progress Adequate |
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 Inadequate |
P140013
|
MINERVA SURGICAL |
MINERVA ENDOMETRIAL ABLATION SYSTEM |
Obstetrics/ Gynecology |
07/27/2015 |
ODE Lead-Minerva Single-Arm Study
|
|
Progress Adequate |
ODE Lead-Minerva Pivotal Study
|
07/25/2015 |
Progress Adequate |
P010047
|
NEOMEND, INC. |
PROGEL PLEURAL AIR LEAK SEALANT |
Anesthesiology |
01/14/2010 |
OSB Lead-Long Term Safety
|
03/16/2015 |
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 |
P100026
|
NEUROPACE INC |
NEUROPACE RNS SYSTEM |
Neurology |
11/14/2013 |
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 |
OSB Lead-Continued F/u -Long Term Treatment (LTT)
|
09/05/2014 |
Progress Adequate |
P100034
|
Novocure, Ltd. |
NOVOCURE LTD'S NOVOTTF-100A TREATMENT KIT |
Neurology |
04/08/2011 |
OSB Lead-Registry Study for Optune System
|
02/09/2016 |
Progress Adequate |
OSB Lead-New Enrollment Study for NovoTTF-100A
|
02/09/2016 |
Revised/Replaced Study |
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 |
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 |
P160001
|
OBALON THERAPEUTICS, INC. |
OBALON BALLOON SYSTEM |
Gastroenterology/ Urology |
09/08/2016 |
OSB Lead-Obalon Balloon System PAS
|
|
Protocol Pending |
P130004
|
OCULAR THERAPEUTICS, INC. |
RESURE SEALANT |
Ophthalmic |
01/08/2014 |
OSB Lead-Device Exposure Registry Study
|
07/21/2016 |
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 |
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-ECD Study
|
09/10/2004 |
Progress Adequate |
OSB Lead-Long Term
|
11/10/2011 |
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 USA
|
|
Progress Inadequate |
OSB Lead-Coflex Actual Practice PAS
|
04/23/2013 |
Revised/Replaced Study |
P120009
|
PFM MEDICAL, INC |
NIT-OCCLUD PDA |
Cardiovascular |
08/16/2013 |
OSB Lead-Nit-Occlud PDA PAS
|
12/16/2016 |
Progress Adequate |
H090002
|
PYREXAR MEDICAL INC |
BSD-2000 HYPERTHERMIA SYSTEM |
Obstetrics/ Gynecology |
11/18/2011 |
OSB Lead-Registry Study
|
11/13/2013 |
Progress Inadequate |
OSB Lead-Deep Hyperthermia and Radiation
|
11/13/2013 |
Revised/Replaced Study |
OSB Lead-Enhanced Surveillance Study
|
11/13/2013 |
Progress Inadequate |
P030050
S002
|
Q-Med AB |
SCULPTRA AESTHETIC |
General & Plastic Surgery |
07/28/2009 |
OSB Lead-Clinical PAS
|
04/23/2014 |
Progress Adequate |
P140012
|
RESHAPE MEDICAL, INC. |
RESHAPE INTEGRATED DUAL BALLOON SYSTEM |
Gastroenterology/ Urology |
07/28/2015 |
OSB Lead-REDUCE PAS
|
01/14/2016 |
Progress Inadequate |
P150034
|
REVISION OPTICS, INCORPORATED |
Raindrop Near Vision Inlay |
Ophthalmic |
06/29/2016 |
ODE Lead Post-Approval Study
|
|
Study Pending |
OSB Lead-Raindrop Near Vision Inlay New Enrollment
|
|
Protocol Pending |
P100020
S017
|
Roche Molecular Systems, Inc. |
COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS |
Microbiology |
07/07/2016 |
OIR Lead-COB-HPV-301 Post Approval Study
|
|
Study Pending |
H110002
|
SECOND SIGHT, LLC. |
ARGUS II RETINAL PROSTHESIS SYSTEM |
Ophthalmic |
02/13/2013 |
OSB Lead-New Enrollment Argus II
|
09/18/2015 |
Progress Inadequate |
OSB Lead-Ext f/u of the Argus II Feasibility Study
|
02/13/2013 |
Progress Adequate |
P070004
|
SIENTRA, INC |
SIENTRA SILICONE GEL BREAST IMPLANTS |
General & Plastic Surgery |
03/09/2012 |
OSB Lead-US Post-Approval Study (US-PAS)
|
05/29/2012 |
Progress Adequate |
OSB Lead-Post-Approval PMA Cohorts Study (PACS)
|
05/29/2012 |
Progress Adequate |
P140026
|
SILK ROAD MEDICAL, INC |
ENROUTE TRANSCAROTID STENT SYSTEM |
Cardiovascular |
05/18/2015 |
OSB Lead-ROADSTER 2 Registry
|
07/19/2016 |
Progress Adequate |
P150030
|
Smith & Nephew, Inc. |
R3 DELTA CERAMIC HIP SYSTEM |
Orthopedic |
10/17/2016 |
ODE Lead-Long-Term F/u of EU patients PAS
|
|
Study Pending |
OSB Lead-Short to Mid-Term f/u of New US Patients
|
|
Study Pending |
P040033
|
SMITH&NEPHEW ORTHOPAEDICS |
BIRMINGHAM HIP RESURFACING (BHR) SYSTEM |
Orthopedic |
05/09/2006 |
OSB Lead-US Study
|
05/09/2006 |
Progress Adequate |
P150004
|
Spinal Modulation, Inc |
Axium Neurostimulator System |
Neurology |
02/11/2016 |
OSB Lead-F/U Axium Neurostimulator System (FANS)
|
05/26/2016 |
Progress Adequate |
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 |
P030054
S173
|
St. Jude Medical |
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) |
Cardiovascular |
11/29/2011 |
OSB Lead-QUAD PAS
|
03/02/2012 |
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 |
P130026
|
St. Jude Medical |
TACTICATH QUARTZ SET |
Cardiovascular |
10/24/2014 |
OSB Lead-TactiCath Quartz PAS
|
08/20/2014 |
Progress Adequate |
P040040
|
St. Jude Medical Cardiovascular Division |
AMPLATZER MUSCULAR VSD OCCLUDER |
Cardiovascular |
09/07/2007 |
OSB Lead-Post Approval Study
|
03/18/2016 |
Progress Adequate |
P120021
|
St. Jude Medical, Inc. |
AMPLATZER PFO OCCLUDER |
Cardiovascular |
10/28/2016 |
OSB Lead-Amplatzer PFO Occulder New Enrollment PAS
|
|
Protocol Pending |
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 |
Progress Adequate |
P030016
|
STAAR SURGICAL CO. |
VISIAN ICL (IMPLANTABLE COLLAMER LENS) |
Ophthalmic |
12/22/2005 |
OSB Lead-Adverse Event Study
|
06/08/2012 |
Progress Adequate |
P040051
|
STELKAST COMPANY |
STELKAST SURPASS ACETABULAR SYSTEM |
Orthopedic |
05/12/2006 |
OSB Lead-Long term
|
05/12/2006 |
Revised/Replaced Study |
P090012
|
STRATA SKIN SCIENCES, INC. |
MELAFIND |
General & Plastic Surgery |
11/01/2011 |
OSB Lead-PAS of MelaFind
|
10/22/2014 |
Progress Adequate |
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 Adequate |
OSB Lead-Actual Conditions of Use Study (STAR 2)
|
09/01/2016 |
Progress Inadequate |
H100006
|
SYNAPSE BIOMEDICAL |
NEURX DIAPHRAGM PACING SYSTEM (DPS) |
Anesthesiology |
09/28/2011 |
OSB Lead-NeuRx DPS
|
09/28/2011 |
Progress Adequate |
P030011
S011
|
SYNCARDIA SYSTEMS, LLC |
SYNCARDIA TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T) SYSTEM |
Cardiovascular |
05/16/2012 |
OSB Lead-INTERMACS Companion
|
11/27/2015 |
Progress Adequate |
OSB Lead-Enhanced Surveillance
|
08/20/2012 |
Revised/Replaced Study |
P070001
|
SYNTHES SPINE |
PRODISC TM-C TOTAL DISC REPLACEMENT |
Orthopedic |
12/17/2007 |
OSB Lead-Long Term Study
|
08/12/2008 |
Progress Adequate |
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 |
P100049
|
TORAX MEDICAL |
LINX REFLUX MANAGEMENT SYSTEM |
Gastroenterology/ Urology |
03/22/2012 |
OSB Lead-Enrollment Study
|
06/22/2012 |
Progress Adequate |
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 |
P130018
|
UROMEDICA INC |
PROACT ADJUSTABLE CONTINENCE THERAPY FOR MEN |
Gastroenterology/ Urology |
11/24/2015 |
OSB Lead-ProAct Post-Approval Study
|
|
Study Pending |
P040050
|
UROPLASTY, LLC |
MACROPLASTIQUE IMPLANTS |
Gastroenterology/ Urology |
10/30/2006 |
OSB Lead-5 year registry - ROSE
|
10/30/2006 |
Progress Adequate |
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 |
P140004
|
VERTIFLEX (R), INCORPORATED |
SUPERION INTERSPINOUS SPACER |
Orthopedic |
05/20/2015 |
ODE Lead-SPACER
|
|
Progress Adequate |
OSB Lead-Superion New Enrollment Study
|
|
Progress Adequate |
P050034
|
VISIONCARE, INC. |
IMPLANTABLE MINIATURE TELESCOPE (IMT) |
Ophthalmic |
07/01/2010 |
OSB Lead-IMT PAS 01 New Enrollment Study
|
01/27/2015 |
Progress Inadequate |
P040043
S051
|
W. L. GORE & ASSOCIATES, INC. |
GORE TAG THORACIC ENDOPROSTHESIS |
Cardiovascular |
09/10/2013 |
OSB Lead-Comprehensive/Linked-Registry Based Surv
|
|
Progress Adequate |
P160004
|
W. L. GORE & ASSOCIATES, INC. |
GORE TIGRIS VASCULAR STENT |
Cardiovascular |
07/27/2016 |
ODE Lead-Continued F/u Study
|
|
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 |
P040037
S060
|
W.L. GORE & ASSOCIATES,INC |
GORE VIABAHN ENDOPROSTHESIS AND GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE |
Cardiovascular |
09/19/2014 |
OSB Lead-New Enrollment Study
|
04/03/2015 |
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 |
OSB Lead-Longterm PAS
|
11/26/2008 |
Progress Adequate |
H120003
|
XVIVO PERFUSION |
XPS WITH STEEN SOLUTION PERFUSATE |
Gastroenterology/ Urology |
08/12/2014 |
OSB Lead-Long-Term Study
|
04/10/2015 |
Progress Inadequate |
P060037
|
ZIMMER, INC. |
NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM |
Orthopedic |
12/10/2007 |
OSB Lead-Long Term Study
|
11/16/2016 |
Progress Inadequate |
P040048
|
ZIMMER, INC. |
TRILOGY AB ACETABULAR SYSTEM |
Orthopedic |
06/28/2006 |
OSB Lead-Long term
|
06/28/2006 |
Revised/Replaced Study |
P010030
S056
|
ZOLL MANUFACTURING CORPORATION |
LIFEVEST WEARABLE DEFIBRILLATOR |
Cardiovascular |
12/17/2015 |
OSB Lead-PMA Post-Approval Study
|
|
Progress Adequate |