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Boston Scientific Corp

3,562 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Precision Spinal Cord Stimulator (SCS)System (P030017/S286)Boston Scientific Corp2017-03-28
Chilli II Cooled Ablation Catheter andCable (P980003/S072)Boston Scientific Corp2017-03-24
Blazer II Cardiac Ablation Catheter and Cable (P920047/S096)Boston Scientific Corp2017-03-24
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S037)Boston Scientific Corp2017-03-24
PROMUS Element Plus Everolimus-Eluting Stent System/Promus PREMIER Everolimus-Eluting Platinum Chronium Coronary Stent S (P110010/S138)Boston Scientific Corp2017-03-24
Precision Montage and Precision Montage MRI (P030017/S284)Boston Scientific Corp2017-03-24
Blazer Open Irrigated Cardiac Ablation System (P150005/S016)Boston Scientific Corp2017-03-24
Express SD Monorail Premounted Stent System (P060006/S080)Boston Scientific Corp2017-03-24
Rotablator Rotational Angioplasty System Guidewire (P900056/S158)Boston Scientific Corp2017-03-24
Precision Montage MRI Spinal Cord Stimulator (SCS)System; Precision Montage Spinal Cord Stimulator (SCS)System; Precisio (P030017/S285)Boston Scientific Corp2017-03-24
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S137)Boston Scientific Corp2017-03-23
PRECISION, PRECISION SPECTRA, PRECISION NOVI, PRECISION MONTAGE, AND PRECISION MONTAGE MRI SCS SYSTEMS (P030017/S274)Boston Scientific Corp2017-03-23
Precision Spinal Cord Stimulation SCS) System (P030017/S282)Boston Scientific Corp2017-03-22
ALTRUA 2 Models: S701, S702, S722 (N970003/S202)Boston Scientific Corp2017-03-21
Precision Spinal Cord Stimulation (SCS) System (P030017/S283)Boston Scientific Corp2017-03-20
WATCHMAN Left Atrial Appendage Closeure Technology (P130013/S012)Boston Scientific Corp2017-03-16
Express SD Renal Monorail Premounted Stent System (P060006/S079)Boston Scientific Corp2017-03-15
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S036)Boston Scientific Corp2017-03-15
SPECTRA WAVEWRITER SPINAL CORD STIMULATOR SYSTEM (P030017/S271)Boston Scientific Corp2017-03-13
INTELLATIP MIFI OPEN-IRRIGATED ABLATION CATHETER (P150005/S008)Boston Scientific Corp2017-03-02
AMS 700 Implantable Penile Prosthesis (N970012/S130)Boston Scientific Corp2017-02-23
ANGIOJET ULTRA XMI/SPIROFLEX/SPIROFLEX VG/DISTAFLEX THROMBECTOMY SET'S (P980037/S059)Boston Scientific Corp2017-02-23
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL (P130030/S031)Boston Scientific Corp2017-02-23
CRT D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P010012/S439)Boston Scientific Corp2017-02-16
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (N970003/S200)Boston Scientific Corp2017-02-16
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S276)Boston Scientific Corp2017-02-14
DYNAGEN, INOGEN, ORIGEN, AUTOGEN CARDIAC RESYNCHRONIZATION THERAPYN DEFIBRILLATOR (CRT_D) (P010012/S444)Boston Scientific Corp2017-02-14
AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S121)Boston Scientific Corp2017-02-10
WOLVERINE CORONARY CUTTING BALLOON (MONORAIL AND OVER-THE-WIRE) (P950020/S079)Boston Scientific Corp2017-02-09
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE) (P130030/S035)Boston Scientific Corp2017-02-09
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S063)Boston Scientific Corp2017-02-08
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S035)Boston Scientific Corp2017-02-03
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S266)Boston Scientific Corp2017-01-25
ACUITY™ Spiral Heart Failure Leads (P010012/S438)Boston Scientific Corp2017-01-20
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S272)Boston Scientific Corp2017-01-17
Incepta, Energen, Punctua, Autogen, Dynagen, Inogen, Origen, Resonate, Vigilant, and Momentum CRT-Ds (P010012/S442)Boston Scientific Corp2017-01-11
Fromio, Vitalio, Ingenio, Advantio, Altrua, Altrua 2, Accolade, Proponent and Essentio (N970003/S201)Boston Scientific Corp2017-01-11
ACUITY X4 STRAIGHT/SPIRAL S/SPIRAL L MODELS (P010012/S441)Boston Scientific Corp2017-01-10
Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S095)Boston Scientific Corp2016-12-23
AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S125)Boston Scientific Corp2016-12-22
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S074)Boston Scientific Corp2016-12-22
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM OVER THE WIRE (OTW) (P130030/S034)Boston Scientific Corp2016-12-21
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) AND AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S123)Boston Scientific Corp2016-12-21
ACUITY X4 lead family shelf life (P010012/S437)Boston Scientific Corp2016-12-21
AMS 700 INFLATABLE PENILE PROSTHESIS WITH INHIBIZONE TREATMENT (N970012/S122)Boston Scientific Corp2016-12-19
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S156)Boston Scientific Corp2016-12-19
ACUITY X4 Lead Models 4671, 4672, 4674, 4675, 4677, 4678 (P010012/S440)Boston Scientific Corp2016-12-19
AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S072)Boston Scientific Corp2016-12-19
AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S069)Boston Scientific Corp2016-12-14
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S062)Boston Scientific Corp2016-12-14
AMS 700 Inflatable Penile Prosthesis (IPP)with and without InhibiZone Treatment and AMS Ambicor Inflatable Penile Prosth (N970012/S119)Boston Scientific Corp2016-12-14
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S026)Boston Scientific Corp2016-12-14
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S011)Boston Scientific Corp2016-12-14
WOLVERINE CORONARY CUTTING BALLOON (P950020/S078)Boston Scientific Corp2016-12-12
AUTOGEN X4 CRT-D MODEL G166, G168 and AUTOGEN CRT-D MODELS G160, G161, G164 (P010012/S424)Boston Scientific Corp2016-12-12
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM. (P130030/S033)Boston Scientific Corp2016-12-12
ESSENTIO Models L100, L101, L121; PROPONENT Models L200, L201, L221; ACCOLADE Models L300, L301, L321; PROPONENT MRI Mod (N970003/S199)Boston Scientific Corp2016-12-12
PROMUS(ELEMENT PLUS /PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S136)Boston Scientific Corp2016-12-12
AMS 800 URINARY CONTROL SYSTEMS, AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S067)Boston Scientific Corp2016-12-09
AMS 700 INFLATABLE PENILE PROSTHESES WITH INHIBIIZONE TREATMENT; AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S118)Boston Scientific Corp2016-12-09
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S135)Boston Scientific Corp2016-12-07
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S127)Boston Scientific Corp2016-12-07
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S032)Boston Scientific Corp2016-12-07
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S268)Boston Scientific Corp2016-12-06
PRECISION SPECTRA, PRECISION MONTAGE AND PRECISION MONTAGE MRI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S267)Boston Scientific Corp2016-12-06
CHILLI II ABLATION CATHETER. (P980003/S071)Boston Scientific Corp2016-12-06
Blazer OI & IntellaNav OI Ablation Catheters (P150005/S012)Boston Scientific Corp2016-12-06
WOLVERINE CORONARY CUTTING BALLOON MONORAIL (MR) AND OVER-THE WIRE (OTW) (P950020/S077)Boston Scientific Corp2016-12-01
Wolverine Coronary Cutting Balloon (Monorail) (P950020/S076)Boston Scientific Corp2016-12-01
AngioJet Ultra Thrombectomy System Console (P980037/S061)Boston Scientific Corp2016-12-01
AMS 700 SERIES INFLATABLE PENILE PROSTHESES (N970012/S124)Boston Scientific Corp2016-12-01
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM, ANGIOJET ULTRA DISTAFLEX THROMBECTOMY SET (P980037/S060)Boston Scientific Corp2016-12-01
AMS 800 URINARY CONTROL SYSTEM (P000053/S073)Boston Scientific Corp2016-12-01
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S198)Boston Scientific Corp2016-11-30
AMS 700 SERIES INFLATABLE PENILE PROSTHESIS (IPP) WITH AND WITHOUT INHIBIZONE TREATMENT (N970012/S120)Boston Scientific Corp2016-11-29
PRECISION MONTAGE MRI AND SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S265)Boston Scientific Corp2016-11-24
PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S264)Boston Scientific Corp2016-11-23
AMS SPHINCTER 800 URINARY CONTROL SYSTEM WITH AND WITHOUT INHIBIZONE TREATMENT (P000053/S071)Boston Scientific Corp2016-11-22
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S001)Boston Scientific Corp2016-11-21
PRECISION SPECTRA, NOVI, MONTAGE MRI AND PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S263)Boston Scientific Corp2016-11-16
PRECISION NOVI MRI, SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S262)Boston Scientific Corp2016-11-16
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 PACEMAKER MODELS (N970003/S196)Boston Scientific Corp2016-11-03
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S038)Boston Scientific Corp2016-11-01
AMS 800 URINARY CONTROL SYSTEMS & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S070)Boston Scientific Corp2016-11-01
WALLSTENT ENDOPROSTHESIS TIPS (P930031/S058)Boston Scientific Corp2016-11-01
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S260)Boston Scientific Corp2016-10-26
Precision, Precision Spectra, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulator (SCS) S (P030017/S261)Boston Scientific Corp2016-10-26
AMS 800 URINARY CONTROL SYSTEM & AMS 800 URINARY CONTROL SYSTEMS WITH INHIBIZONE TREATMENT (P000053/S068)Boston Scientific Corp2016-10-21
PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEM; MRI SPINAL CORD STIMULATOR (SCS) SYSTEM. (P030017/S255)Boston Scientific Corp2016-10-18
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S134)Boston Scientific Corp2016-10-14
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DYNAGEN, INOGEN, ORIGEN, X4 CRT-D: (P010012/S434)Boston Scientific Corp2016-10-13
DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 NG3 CRT-D; INCEPTA, ENERGEN, PUNCTUA PROGENY CRT-D (P010012/S433)Boston Scientific Corp2016-10-12
INGENIO 2, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA PACEMAKERS; ADVANTIO, INGENIO, VITALIO, FORMIO (IPG) (N970003/S195)Boston Scientific Corp2016-10-12
WALLSTENT ENDOPROSTHESIS TIPS (P930031/S057)Boston Scientific Corp2016-10-12
Rotablator Rotational Atherectomy System (P900056/S155)Boston Scientific Corp2016-10-11
PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S259)Boston Scientific Corp2016-10-06
PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S258)Boston Scientific Corp2016-10-05
ADVANTIO; INGENIO; VITALIO; FORMIO; ESSENTIO; PROPONENT; ACCOLADE; ALTRUA 2 PACEMAKERS. (N970003/S194)Boston Scientific Corp2016-09-29
ORIGEN; INOGEN; DYNAGEN; PUNCTUA; ENERGEN; INCEPTA CRT-Ds (P010012/S432)Boston Scientific Corp2016-09-29
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S133)Boston Scientific Corp2016-09-29
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