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Boston Scientific Corp

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

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RecordFirmDate
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S214)Boston Scientific Corp2015-03-13
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013)Boston Scientific Corp2015-03-13
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S030)Boston Scientific Corp2015-03-06
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S065)Boston Scientific Corp2015-03-06
INOGEN, ORIGEN AND DYNAGEN CRT-DS (P010012/S385)Boston Scientific Corp2015-03-01
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S009)Boston Scientific Corp2015-02-25
FORMIO, VITALIO, INGENIO, ADVANTIO, ACCOLADE, PROPONENT, ESSENTIO, & ALTRUA 2 PACEMAKERS (N970003/S170)Boston Scientific Corp2015-02-25
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S212)Boston Scientific Corp2015-02-25
DYNAGEN,INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR, (P010012/S384)Boston Scientific Corp2015-02-23
PRECISION SPINAL CORD STIMULATOR(SCS) SYSTEM AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S210)Boston Scientific Corp2015-02-13
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S055)Boston Scientific Corp2015-02-12
PRECISION SPECTRA SYSTEM (P030017/S209)Boston Scientific Corp2015-02-12
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S104)Boston Scientific Corp2015-02-12
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S029)Boston Scientific Corp2015-02-09
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S113)Boston Scientific Corp2015-02-04
FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S071)Boston Scientific Corp2015-02-04
NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA) (P010012/S376)Boston Scientific Corp2015-01-29
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S102)Boston Scientific Corp2015-01-28
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S053)Boston Scientific Corp2015-01-28
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S211)Boston Scientific Corp2015-01-21
EASYTRAK 2+ IS-1 CORONARY VENOUS STEROID ELUTING DUAL ELECTRODE PACE/SENSE LEADS (P010012/S380)Boston Scientific Corp2015-01-21
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE (P100023/S104)Boston Scientific Corp2015-01-21
REBEL MONORAIL AND OVER-THE-WIRE PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S008)Boston Scientific Corp2015-01-15
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM,PROMUS PREMIER EVEROLIMUS-ELUTING PLATINU (P110010/S101)Boston Scientific Corp2015-01-14
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S112)Boston Scientific Corp2015-01-14
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S007)Boston Scientific Corp2015-01-14
CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S381)Boston Scientific Corp2015-01-09
COGNIS, ENERGEN, PUNCTUA, INCEPTA,ORIGEN, INOGEN, DYNAGEN, AUTOGEN, (CRT-D RESYNCHRONIZATION DEVICES (P010012/S377)Boston Scientific Corp2015-01-06
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (PACEMAKER DEVICES) (N970003/S169)Boston Scientific Corp2015-01-06
DYNAGEN, INOGEN, ORIGEN CRT-DS (P010012/S382)Boston Scientific Corp2015-01-06
ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S379)Boston Scientific Corp2014-12-19
MAESTRO 4000 CARDIAC ABLATION SYSTEM (P980003/S052)Boston Scientific Corp2014-12-19
PRECISION SPINAL CORD STIMULATOR (SCS)SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S202)Boston Scientific Corp2014-12-19
MAESTRO 4000 CARDIAC ABLATION SYSTEM (P920047/S072)Boston Scientific Corp2014-12-19
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S100)Boston Scientific Corp2014-12-18
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S111)Boston Scientific Corp2014-12-18
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- OVER THE WIRE; ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM-MONORAIL (P100023/S110)Boston Scientific Corp2014-12-18
CHILLI II COOLED ABLATION SYSTEM (P980003/S055)Boston Scientific Corp2014-12-17
BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S075)Boston Scientific Corp2014-12-17
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S143)Boston Scientific Corp2014-12-12
ORIGEN, ORIGEN X4,DYNAGEN,DYNAGEN X4,INOGEN,INOGEN X4 CRT-DS (P010012/S378)Boston Scientific Corp2014-12-12
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S102)Boston Scientific Corp2014-12-08
AMS 800TM URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S051)Boston Scientific Corp2014-12-08
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S062)Boston Scientific Corp2014-12-08
AMS 700 TM INFLATABLE PENILE PROSTHESIS(IPP) WITH INHIBIZONE TREATMENT (N970012/S099)Boston Scientific Corp2014-12-08
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S089)Boston Scientific Corp2014-12-08
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S139)Boston Scientific Corp2014-12-08
CHILLI II COOLED ABLATION CATHETER (P980003/S053)Boston Scientific Corp2014-12-08
BLAZER II CARDIAC ABLATION CATHETER (P920047/S073)Boston Scientific Corp2014-12-08
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S208)Boston Scientific Corp2014-11-26
AMS ACTION NEOSPHINCTER ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S028)Boston Scientific Corp2014-11-18
AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S052)Boston Scientific Corp2014-11-18
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S101)Boston Scientific Corp2014-11-18
ADVANTIO, INGENIO, VITALIO, FORMIO PACEMAKERS (N970003/S168)Boston Scientific Corp2014-11-17
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S207)Boston Scientific Corp2014-11-14
DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 CRT-D (P010012/S371)Boston Scientific Corp2014-11-07
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S100)Boston Scientific Corp2014-11-06
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S109)Boston Scientific Corp2014-11-05
PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S098)Boston Scientific Corp2014-11-05
PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S097)Boston Scientific Corp2014-10-30
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S006)Boston Scientific Corp2014-10-30
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S108)Boston Scientific Corp2014-10-30
CHILLI II COOLED ABLATION CATHETER (P980003/S054)Boston Scientific Corp2014-10-28
DYNAGEN, INOGEN, ORGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) (P010012/S374)Boston Scientific Corp2014-10-28
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S107)Boston Scientific Corp2014-10-22
EASY TRAK 2 FAMILY (P010012/S375)Boston Scientific Corp2014-10-22
PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S094)Boston Scientific Corp2014-10-22
REBEL PLATINUM CHROMINUM CORONARY STENT SYSTEM (P130030/S005)Boston Scientific Corp2014-10-22
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S074)Boston Scientific Corp2014-10-21
ALTRUA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S167)Boston Scientific Corp2014-10-21
REBEL PTCR CORONARY STENT SYSTEM (P130030/S004)Boston Scientific Corp2014-10-21
DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D (P010012/S373)Boston Scientific Corp2014-10-20
BLAZER II TEMPERATURE ABLATION CATHETERS AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS USED WITH MAESTRO 3000 CARI (P920047/S071)Boston Scientific Corp2014-10-17
CHILLI II COOLED ABLATION CATHETER (P980003/S050)Boston Scientific Corp2014-10-17
DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS (P010012/S372)Boston Scientific Corp2014-10-16
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S060)Boston Scientific Corp2014-10-10
PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLINUS-ELTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (P110010/S085)Boston Scientific Corp2014-10-10
ION PACLITAXEL-ELUTING PLATINUM CHRONIUM CORONARY STENT SYSTEM (P100023/S098)Boston Scientific Corp2014-10-10
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S204)Boston Scientific Corp2014-10-09
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S205)Boston Scientific Corp2014-10-09
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S203)Boston Scientific Corp2014-10-02
TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P060008/S105)Boston Scientific Corp2014-09-29
INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN AND ORIGEN CRT-DS (P010012/S370)Boston Scientific Corp2014-09-18
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S026)Boston Scientific Corp2014-09-17
PROMUS ELEMENT PLUS & PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM STENT SYSTEMS (P110010/S090)Boston Scientific Corp2014-09-17
PROMUS ELEMENT PLUS PLATINUM CHROMIUM EVEROLIMUS-ELUTING CORONARY STENT SYSTEM & PROMUS PREMIER EVEROLIMUS-ELUTING PLATI (P110010/S092)Boston Scientific Corp2014-09-12
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S105)Boston Scientific Corp2014-09-12
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S003)Boston Scientific Corp2014-09-12
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S093)Boston Scientific Corp2014-09-11
FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S069)Boston Scientific Corp2014-09-11
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S106)Boston Scientific Corp2014-09-11
ORIGEN, INOGEN, DYNAGEN, CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) (P010012/S369)Boston Scientific Corp2014-09-10
ANGIOJET FAMILY OF THROMBECTOMY SETS (P980037/S043)Boston Scientific Corp2014-09-04
ANGIOJET ULTRA THOMRBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THOMBRBECTOMY SET, VG THOMRBECTOMY SET, DISTAFLEX THOMBRBECTOM (P980037/S042)Boston Scientific Corp2014-09-02
FLEXTOME CUTTING BALLOON MICROSURGICAL DILATATION DEVICE (P950020/S068)Boston Scientific Corp2014-08-29
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S076)Boston Scientific Corp2014-08-28
PRECISION SPECTRA SYSTEM (P030017/S201)Boston Scientific Corp2014-08-28
TELIGEN, INCEPTA, ENERGEN, PUNCTUA, DYNAGEN, INOGEN, ORIGEN; ICD'S (P010012/S368)Boston Scientific Corp2014-08-27
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S028)Boston Scientific Corp2014-08-26
NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D),DYNAGEN CRT-D,DYNAGEN X4 CRT-D,INOGEN CRT-D,INOGEN X4 CRT-D, (P010012/S359)Boston Scientific Corp2014-08-26
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Every clearance here is in the API, with alerts when new ones post.