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Boston Scientific Corp

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

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RecordFirmDate
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S006)Boston Scientific Corp2016-04-05
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S003)Boston Scientific Corp2016-04-05
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S249)Boston Scientific Corp2016-04-01
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S002)Boston Scientific Corp2016-03-30
DYNAGEN™ CRT-D Models G150, G151, G154, G156, G158; INOGEN™ CRT-D (P010012/S406)Boston Scientific Corp2016-03-28
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S248)Boston Scientific Corp2016-03-24
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S022)Boston Scientific Corp2016-03-23
DYNAGEN ™ CRT-D G150, G151, G154; DYNAGEN ™ X4 CRT-D G156, G158; INOGEN ™ CRT-D G140, G141; INOGEN ™ X4 CRT-D G146, G148 (P010012/S412)Boston Scientific Corp2016-03-23
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S121)Boston Scientific Corp2016-03-23
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S247)Boston Scientific Corp2016-03-18
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S004)Boston Scientific Corp2016-03-18
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S120)Boston Scientific Corp2016-03-18
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S072)Boston Scientific Corp2016-03-18
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S021)Boston Scientific Corp2016-03-18
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S024)Boston Scientific Corp2016-03-17
ROTABLATOR(R) (P900056/S152)Boston Scientific Corp2016-03-11
Dynagen™ Models G150, G151, G154, G156, G158; Inogen™ Models G140, G141, G146, G148; Origen™ Models G050, G051, G056, G0 (P010012/S410)Boston Scientific Corp2016-03-09
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S090)Boston Scientific Corp2016-03-04
CHILLI COOLED RF ABLATION SYSTEM (P980003/S065)Boston Scientific Corp2016-03-04
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S089)Boston Scientific Corp2016-03-04
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S246)Boston Scientific Corp2016-03-04
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT (P010012/S409)Boston Scientific Corp2016-03-03
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S119)Boston Scientific Corp2016-02-26
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S020)Boston Scientific Corp2016-02-26
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S071)Boston Scientific Corp2016-02-26
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005)Boston Scientific Corp2016-02-24
PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S102)Boston Scientific Corp2016-02-24
ACUITY X4 STRAIGHT (4671,4672), SPIRAL S (4674,4675), SPIRAL L (4677,4678) LEADS; SUTURELESS SLEEVE & FLUSHING TOOL/WIRE (P010012/S398)Boston Scientific Corp2016-02-22
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHRONIMUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATIN (P110010/S116)Boston Scientific Corp2016-02-16
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S123)Boston Scientific Corp2016-02-16
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S017)Boston Scientific Corp2016-02-16
ANGIOJET ULTRA THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY, ANGIOJ (P980037/S056)Boston Scientific Corp2016-02-12
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S018)Boston Scientific Corp2016-02-12
ANGIOJET ULTRA XMI THROMBECTOMY SET; ANGIOJET ULTRA SPIROFLEX & SPIROFLEX VG THROMBECTOMY SET; ANGIOLET ULTRA DISTAFLEX (P980037/S055)Boston Scientific Corp2016-02-10
CHILLI II COOLED ABLATION SYSTEM (P920047/S083)Boston Scientific Corp2016-02-08
CHILLI II COOLED ABLATION SYSTEM (P980003/S061)Boston Scientific Corp2016-02-08
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, CRT-D RESYNCHRONIZATION DEVICES (P010012/S408)Boston Scientific Corp2016-02-05
ADVANTIO, INGENIO, VITALIO, FORMIO ESSENTIO, ACCOLADE, PROPONENT, AND ALTRUA 2 SUPPORTED BY LATITUDE CONSULT ONLY) (PACE (N970003/S184)Boston Scientific Corp2016-02-05
AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S056)Boston Scientific Corp2016-02-04
AMS ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S029)Boston Scientific Corp2016-02-04
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S105)Boston Scientific Corp2016-02-04
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S111)Boston Scientific Corp2016-02-03
ESSENTIO; PROPONENT; ACCOLADE ; ALTRUA 2 PACEMAKERS (N970003/S185)Boston Scientific Corp2016-02-03
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S244)Boston Scientific Corp2016-01-15
ALAIR BRONCHIAL THERMOPLASTY SYSTEM (P080032/S016)Boston Scientific Corp2015-12-29
ORIGEN, INOGEN, AND DYNAGEN CRT-D, INCEPTA ENERGEN PUNCTUA CRT-D, COGNIS CRT-D (P010012/S405)Boston Scientific Corp2015-12-21
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S054)Boston Scientific Corp2015-12-18
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S243)Boston Scientific Corp2015-12-18
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S022)Boston Scientific Corp2015-12-17
BLAZER PRIME HTD, BLAZER II, BLAZER II HTD (P920047/S087)Boston Scientific Corp2015-12-17
CAROTID WALLSTENT MONORAIL STENT SYSTEM (P050019/S023)Boston Scientific Corp2015-12-16
ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S046)Boston Scientific Corp2015-12-14
ANGIOJET XMI THROMBECTOMY SET, ANGIOJET SPIROFLEX THROMBECTOMY SET, ANGIOJEET SPIROFLEX VG THROMBECTOMY SET, ANGIOJET DI (P980037/S053)Boston Scientific Corp2015-12-11
ANGIOJET ULTRA XMI THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET,ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S052)Boston Scientific Corp2015-12-09
DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S404)Boston Scientific Corp2015-12-07
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION NOVI SPI (P030017/S242)Boston Scientific Corp2015-12-04
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S117)Boston Scientific Corp2015-12-03
ANGIOJET ULTRA XMI THROMBECTOMY SET, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMOBECTOMY SET (P980037/S051)Boston Scientific Corp2015-12-02
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S032)Boston Scientific Corp2015-11-30
PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S240)Boston Scientific Corp2015-11-24
DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D, ORIGEN CRT-D & X4 CRT-D (P010012/S403)Boston Scientific Corp2015-11-19
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S183)Boston Scientific Corp2015-11-19
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S239)Boston Scientific Corp2015-11-18
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S238)Boston Scientific Corp2015-11-18
PRECISION,PRECISION SPECTRA, PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S234)Boston Scientific Corp2015-11-12
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S182)Boston Scientific Corp2015-11-03
ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S050)Boston Scientific Corp2015-11-02
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S112)Boston Scientific Corp2015-10-30
ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SETS (P980037/S049)Boston Scientific Corp2015-10-30
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S070)Boston Scientific Corp2015-10-23
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S237)Boston Scientific Corp2015-10-22
PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNHRONIZATION THERAPY-DEFIBRILLATOR (P010012/S402)Boston Scientific Corp2015-10-21
ORIGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4 CRT-D; DYNAGEN CRT-D, X4 CRT-D CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS (P010012/S401)Boston Scientific Corp2015-10-19
AMS 700 AMBICOR INFLATABLE PENILE PROTHESIS (N970012/S113)Boston Scientific Corp2015-10-14
AMS 800 URINARY CONTROL SYSTEM (P000053/S061)Boston Scientific Corp2015-10-14
ROTABLATOR ROTATIONAL ANGOPLASTY SYSTEM GUIDEWIRE (P900056/S151)Boston Scientific Corp2015-10-13
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S064)Boston Scientific Corp2015-10-13
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S086)Boston Scientific Corp2015-10-13
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S236)Boston Scientific Corp2015-10-09
INCEPTA CRT D, ENERGEN CRT D, PUNCTUA CRT-D, DYNAGEN CRT-D, INOGEN CRT D, ORIGEN CRT-D (P010012/S400)Boston Scientific Corp2015-10-07
DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D (P010012/S399)Boston Scientific Corp2015-10-02
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S085)Boston Scientific Corp2015-10-01
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (OTW AND MR) (P100023/S122)Boston Scientific Corp2015-09-29
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S033)Boston Scientific Corp2015-09-25
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S230)Boston Scientific Corp2015-09-22
ANGIOJET ULTRA XMI THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THROMBECTOMY SET, ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY (P980037/S048)Boston Scientific Corp2015-09-21
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S229)Boston Scientific Corp2015-09-18
ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S047)Boston Scientific Corp2015-09-17
COGNIS, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4, CRT-D (P010012/S395)Boston Scientific Corp2015-09-17
EPT-1000 CARDIAC ABLATION SYSTEM (P920047/S084)Boston Scientific Corp2015-09-15
CHILLI II COOLED ABLATION SYSTEM (P980003/S063)Boston Scientific Corp2015-09-15
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S233)Boston Scientific Corp2015-09-10
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY (P130013/S003)Boston Scientific Corp2015-09-03
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S115)Boston Scientific Corp2015-09-03
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S232)Boston Scientific Corp2015-09-02
REBEL MONORAIL AND OVER THE WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S016)Boston Scientific Corp2015-09-02
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S069)Boston Scientific Corp2015-09-02
WATCHMAN LAA CLOSURE TECHNOLOGY (P130013/S005)Boston Scientific Corp2015-09-02
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S231)Boston Scientific Corp2015-08-25
DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, ORIGEN CRT-D, X4 CRT-D, INCEPTA TM ICD, ENERGEN TM ICD & PUNCTUA TM ICD (P010012/S397)Boston Scientific Corp2015-08-21
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Every clearance here is in the API, with alerts when new ones post.