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Boston Scientific Corp

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

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RecordFirmDate
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S150)Boston Scientific Corp2015-08-20
CHILLI II COOLED ABLATION CATHETER (P980003/S062)Boston Scientific Corp2015-08-19
WALLSTENT ENDOPROSTHESIS TIPS (P930031/S054)Boston Scientific Corp2015-08-12
EXPRESS SD RENAL MONORAIL PREMOUNTED SYSTEM (P060006/S064)Boston Scientific Corp2015-08-12
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S181)Boston Scientific Corp2015-08-08
INCEPTA, ENERGEN, PUNCTUA, DYNAGEN,INOGEN,ORIGEN CRT-D (P010012/S396)Boston Scientific Corp2015-08-08
AMS 700, AMS AMBICOR, AMS 700 WITH MS PUMP INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S110)Boston Scientific Corp2015-08-04
DYNAGEN, INOGEN, ORIGEN, CRT-D DEVICES (P010012/S394)Boston Scientific Corp2015-07-31
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S217)Boston Scientific Corp2015-07-30
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S114)Boston Scientific Corp2015-07-30
ADVANTIO,INGENIO,VITALIO,FORMIO,ESSENTIO,ACCOLADE,PROPONENT PACEMAKERS (N970003/S175)Boston Scientific Corp2015-07-21
COGNIS,ENERGEN,PUNCTUA,INCEPTA,ORIGEN,INOGEN,DYNAGEN,AUTOGEN CRT-DS (P010012/S387)Boston Scientific Corp2015-07-21
ALTURA 2, ESSENTIO, PROPONENT AND ACCOLADE (N970003/S178)Boston Scientific Corp2015-07-20
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S179)Boston Scientific Corp2015-07-20
EASYTRAK 2 CORONARY SINUS PACING LEADS, EASYTRAK 3 CORONARY SINUS PACING LEADS, ACUITY SPIRAL CORONARY SINUS PACING LEAD (P010012/S391)Boston Scientific Corp2015-07-16
ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S177)Boston Scientific Corp2015-07-16
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CORONARY STENT SYSTEM (P110010/S113)Boston Scientific Corp2015-07-09
ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER (P900056/S149)Boston Scientific Corp2015-07-09
PROMUS ELEMENT PLUS EVEROLIMUS - ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S099)Boston Scientific Corp2015-07-07
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S112)Boston Scientific Corp2015-07-01
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S121)Boston Scientific Corp2015-07-01
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S014)Boston Scientific Corp2015-07-01
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S015)Boston Scientific Corp2015-07-01
PROMUS ELEMENT PLUS EVEROLIMUS ELUTING STENT SYSTEM, PROMUS PREMIER EVEROLIMUS ELUTING STENT SYSTEM (P110010/S111)Boston Scientific Corp2015-07-01
ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S120)Boston Scientific Corp2015-07-01
EASYTRAK 2 AND EASYTRAK 3 CORONARY VENOUS STEROID ELUTING BIPOLAR PACE/SENSE LEAD,ACUITY SPIRAL LEAD (P010012/S390)Boston Scientific Corp2015-06-30
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S228)Boston Scientific Corp2015-06-26
PROMUS ELEMENT PLUS/PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S109)Boston Scientific Corp2015-06-26
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S118)Boston Scientific Corp2015-06-26
AMS 700/AMBICOR INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S109)Boston Scientific Corp2015-06-24
ACTICON NEOSPHINCTER ARTIFICIAL BOWEL SPHINCTER (P010020/S033)Boston Scientific Corp2015-06-24
AMS 800 URINARY CONTROL SYSTEM (P000053/S060)Boston Scientific Corp2015-06-24
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S108)Boston Scientific Corp2015-06-23
ION PACLITAXEL ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S117)Boston Scientific Corp2015-06-23
DYNAGEN, INOGEN, ORIGEN, PUNCTUA, ENERGEN, INCEPTA ICD'S (P010012/S389)Boston Scientific Corp2015-06-22
ROTAWIRE ELITE GUIDEWIRE (P900056/S145)Boston Scientific Corp2015-06-19
ROTOBLATOR ROTATIONAL ANGIOPLASTY SYSTEM (P900056/S147)Boston Scientific Corp2015-06-12
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S227)Boston Scientific Corp2015-06-11
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S116)Boston Scientific Corp2015-06-11
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S107)Boston Scientific Corp2015-06-11
DYNAGEN CRT-D, DYNAGEN X4 CRT-D,INOGEN CRT-D, INOGEN X4 CRT-D,ORIGEN CRT-D, ORIGEN X4 CRT-D, INCEPTA TM ICD,ENERGEN TM I (P010012/S388)Boston Scientific Corp2015-06-04
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM-OTW (P110010/S105)Boston Scientific Corp2015-06-02
PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM (MONORAIL & OVER-THE- (P110010/S096)Boston Scientific Corp2015-06-01
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE TECHNOLOGY (P130013/S002)Boston Scientific Corp2015-06-01
IMPLANTABLE PULSE GENERATOR (PG), ESSENTIO, PROPONENT, ACCOLADE, ALTRUA2 (N970003/S176)Boston Scientific Corp2015-05-31
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S226)Boston Scientific Corp2015-05-29
BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER (P920047/S080)Boston Scientific Corp2015-05-29
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S115)Boston Scientific Corp2015-05-28
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P130030/S012)Boston Scientific Corp2015-05-28
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S146)Boston Scientific Corp2015-05-28
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM/PROMUS PREMIER EVEROLIMUS-ELUTING CHROMIUM CORONARY STENT SYSTEM (P110010/S106)Boston Scientific Corp2015-05-28
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S067)Boston Scientific Corp2015-05-28
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S059)Boston Scientific Corp2015-05-28
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S081)Boston Scientific Corp2015-05-28
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR SYSTEMS (P030017/S216)Boston Scientific Corp2015-05-27
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S173)Boston Scientific Corp2015-05-19
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 PACEMAKERS (N970003/S174)Boston Scientific Corp2015-05-19
CAROTID WALLSTENT ENDOPROSTHESIS (P050019/S021)Boston Scientific Corp2015-05-15
ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM (P980037/S044)Boston Scientific Corp2015-05-14
ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM (P900056/S144)Boston Scientific Corp2015-05-12
PRECISION SPECTRA TM SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S223)Boston Scientific Corp2015-05-11
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S079)Boston Scientific Corp2015-05-11
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S224)Boston Scientific Corp2015-05-07
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S059)Boston Scientific Corp2015-05-06
AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWL SPHINCTER (ABS) (P010020/S032)Boston Scientific Corp2015-05-06
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) (N970012/S108)Boston Scientific Corp2015-05-06
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S222)Boston Scientific Corp2015-05-04
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S221)Boston Scientific Corp2015-04-29
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S213)Boston Scientific Corp2015-04-28
BLAZER II/ II HTD, BLAZER PRIME HTD SYSTEM CABLES (P920047/S078)Boston Scientific Corp2015-04-23
CHILLI II COOLED CATHETER ABLATION SYSTEM (P980003/S058)Boston Scientific Corp2015-04-23
AMS 800 URINARY CONTROL SPHINCTER (P000053/S058)Boston Scientific Corp2015-04-15
AMS ACTICON NEOSPHINCTER (P010020/S031)Boston Scientific Corp2015-04-15
AMS 700 INFLATABLE PENILE PROSTHESIS,AMS AMBICOR PENILE PROSTHESIS (N970012/S107)Boston Scientific Corp2015-04-15
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S220)Boston Scientific Corp2015-04-14
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S106)Boston Scientific Corp2015-04-13
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S218)Boston Scientific Corp2015-04-10
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM, PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S219)Boston Scientific Corp2015-04-10
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S011)Boston Scientific Corp2015-04-09
PROMUS ELEMENT PLUS AND PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S104)Boston Scientific Corp2015-04-08
AMS 800 ARTIFICIAL URINARY SPHINCTER (AUS) (P000053/S057)Boston Scientific Corp2015-04-08
AMS ACTICON NEOSPHINCTER- ARTIFICIAL BOWEL SPHINCTER (ABS) (P010020/S030)Boston Scientific Corp2015-04-08
AMS 700 INFLATABLE PENILE PROSTHESIS (N970012/S103)Boston Scientific Corp2015-04-07
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S054)Boston Scientific Corp2015-04-07
BLAZER II, BLAZER II HTD AND BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S076)Boston Scientific Corp2015-04-06
CHILLI II COOLED ABLATION CATHETERS (P980003/S056)Boston Scientific Corp2015-04-06
INOGEN, ORIGEN AND DYNAGEN CRT-D'S (P010012/S386)Boston Scientific Corp2015-04-02
ANGIOJET ULTRA THROMBECTOMY SYSTEM CONSOLE (P980037/S045)Boston Scientific Corp2015-03-31
PRECISION SPECTRA SPINAL CORD STUMULATOR (SCS) SYSTEM (P030017/S206)Boston Scientific Corp2015-03-31
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S031)Boston Scientific Corp2015-03-27
ADVANTIO, INGENIO, VITALIO, FORMIO PGS (N970003/S172)Boston Scientific Corp2015-03-27
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S215)Boston Scientific Corp2015-03-25
BLAZER II /BLAZER II HTD,BLAZER PRIME (XP/HTD) ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES (P920047/S077)Boston Scientific Corp2015-03-24
CHILLI II COOLED ABLATION SYSTEM (P980003/S057)Boston Scientific Corp2015-03-24
ADVANTIO, INGENIO AND VITALIO PACEMAKERS (N970003/S171)Boston Scientific Corp2015-03-23
ACUITY SPIRAL LEADS (P010012/S383)Boston Scientific Corp2015-03-19
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S010)Boston Scientific Corp2015-03-17
ION (TAXUS ELEMENT) PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S114)Boston Scientific Corp2015-03-17
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S103)Boston Scientific Corp2015-03-17
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S066)Boston Scientific Corp2015-03-17
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Every clearance here is in the API, with alerts when new ones post.