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Boston Scientific Corporation

944 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S016)Boston Scientific Corporation2016-09-02
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S019)Boston Scientific Corporation2016-08-29
WALLSTENT ENDOPROSTHESIS (VENOUS) (P980033/S045)Boston Scientific Corporation2016-08-24
Emblem SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S060)Boston Scientific Corporation2016-08-19
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S018)Boston Scientific Corporation2016-08-19
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S017)Boston Scientific Corporation2016-08-18
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S006)Boston Scientific Corporation2016-08-17
EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S042)Boston Scientific Corporation2016-08-11
SYNERGY EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P150003/S016)Boston Scientific Corporation2016-08-10
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S015)Boston Scientific Corporation2016-08-09
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S058)Boston Scientific Corporation2016-08-08
EMBLEM S-ICD SYSTEM (P110042/S061)Boston Scientific Corporation2016-08-02
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM(OVER-THE-WIRE& MONORAIL) (P150003/S003)Boston Scientific Corporation2016-07-29
ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S002)Boston Scientific Corporation2016-07-19
EXPRESS LD ILIAC OVER-THE-WIRE PREMOUNTED STENT SYSTEM (P090003/S041)Boston Scientific Corporation2016-07-13
SUBCUTANEOUS ICD DEVICES: EMBLEM. (P110042/S059)Boston Scientific Corporation2016-07-08
ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S003)Boston Scientific Corporation2016-07-05
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (Monorail) (P150003/S013)Boston Scientific Corporation2016-06-17
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S014)Boston Scientific Corporation2016-06-16
INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S014)Boston Scientific Corporation2016-06-01
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S011)Boston Scientific Corporation2016-05-31
INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM (P140028/S013)Boston Scientific Corporation2016-05-27
ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S003)Boston Scientific Corporation2016-05-23
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S012)Boston Scientific Corporation2016-05-20
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM MR & OTW (P150003/S010)Boston Scientific Corporation2016-05-18
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S012)Boston Scientific Corporation2016-05-11
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S010)Boston Scientific Corporation2016-05-11
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S009)Boston Scientific Corporation2016-05-10
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S009)Boston Scientific Corporation2016-04-12
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S008)Boston Scientific Corporation2016-04-08
SYNERGY EVEROLIMUS ELUTING PLATINUM CHROMIUN CORONARY STENT SYSTEM MONORAIL & OVER THE WIRE. (P150003/S002)Boston Scientific Corporation2016-04-07
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S011)Boston Scientific Corporation2016-03-30
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S008)Boston Scientific Corporation2016-03-21
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S007)Boston Scientific Corporation2016-03-18
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S039)Boston Scientific Corporation2016-03-18
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S040)Boston Scientific Corporation2016-03-17
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S007)Boston Scientific Corporation2016-03-07
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S005)Boston Scientific Corporation2016-03-04
ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S001)Boston Scientific Corporation2016-03-02
ORBERA INTRAGASTRIC BALLOON SYSTEM (P140008/S002)Boston Scientific Corporation2016-02-26
EMBLEM (SUBCUTANEOUS ICD DEVICES) (P110042/S057)Boston Scientific Corporation2016-02-05
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIMUM CORONARY STENT SYSTEM MONORAIL & OVER-THE-WIRE. (P150003/S004)Boston Scientific Corporation2016-02-04
RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S003)Boston Scientific Corporation2016-01-22
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012/S001)Boston Scientific Corporation2016-01-14
RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT (P140012/S004)Boston Scientific Corporation2015-12-31
RESHAPE INTEGRATED DUAL BALLOON SYSTEM,RESHAPE BALLOON ASSEMBLY,RESHAPE REMOVAL CATHETER,RESHAPE VALVE SEALANT (P140012/S002)Boston Scientific Corporation2015-12-21
SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) (P110042/S056)Boston Scientific Corporation2015-12-09
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S001)Boston Scientific Corporation2015-12-03
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S006)Boston Scientific Corporation2015-11-30
EMBLEM S-ICD SYSTEM (P110042/S055)Boston Scientific Corporation2015-11-19
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S005)Boston Scientific Corporation2015-11-16
INNOVA (TM) VASCULAR SELF EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S004)Boston Scientific Corporation2015-11-09
EMBLEM S-ICD PULSE GENERATOR (P110042/S053)Boston Scientific Corporation2015-11-04
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S003)Boston Scientific Corporation2015-10-23
GEN 2 S-ICD & SQ-RX PULSE GENERATOR, SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFRILLATOR (P110042/S052)Boston Scientific Corporation2015-10-21
EMBLEM S-ICD PULSE GENERATOR (P110042/S051)Boston Scientific Corporation2015-10-19
EMBLEM SUBCUTANEOUS IMPLANTABLE CARDIAC DEFIBRILLATOR (S ICD ) (P110042/S050)Boston Scientific Corporation2015-10-07
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S002)Boston Scientific Corporation2015-10-02
SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003)Boston Scientific Corporation2015-10-02
INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028/S001)Boston Scientific Corporation2015-09-21
GENE2.0 S-ICD: A209 (P110042/S049)Boston Scientific Corporation2015-08-21
EXPRESS LD ILIAC PREMOUNTED SYSTEM (P090003/S037)Boston Scientific Corporation2015-08-12
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S043)Boston Scientific Corporation2015-08-12
ORBERA INTRAGASTRIC BALLOON (P140008)Boston Scientific Corporation2015-08-05
ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S001)Boston Scientific Corporation2015-08-03
RESHAPE INTEGRATED DUAL BALLOON SYSTEM (P140012)Boston Scientific Corporation2015-07-28
EMBLEM SUBCUTANEOUS ICD (P110042/S045)Boston Scientific Corporation2015-07-21
INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM (P140028)Boston Scientific Corporation2015-07-21
ENROUTE TRANSCAROTID STENT SYSTEM (P140026)Boston Scientific Corporation2015-05-18
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S038)Boston Scientific Corporation2015-04-09
EMBLEM S ICD SYSTEM (P110042/S043)Boston Scientific Corporation2015-03-13
EXPRESS LD ILIAC PREMOUNTEDSTENT SYSTEM (P090003/S038)Boston Scientific Corporation2015-03-06
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S042)Boston Scientific Corporation2014-11-25
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S041)Boston Scientific Corporation2014-10-23
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S035)Boston Scientific Corporation2014-10-10
EXPRESS LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S032)Boston Scientific Corporation2014-10-10
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S029)Boston Scientific Corporation2014-09-04
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S040)Boston Scientific Corporation2014-08-27
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S029)Boston Scientific Corporation2014-08-22
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S033)Boston Scientific Corporation2014-06-30
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S037)Boston Scientific Corporation2014-06-27
SUBCURANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S039)Boston Scientific Corporation2014-06-27
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (P110042/S035)Boston Scientific Corporation2014-05-30
CAMERON HEALTH SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S034)Boston Scientific Corporation2014-05-29
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL (P110042/S033)Boston Scientific Corporation2014-05-28
WALLSTENT VENOUS ENDOPROSTHESIS (P980033/S041)Boston Scientific Corporation2014-05-23
CAMERON HEALTH SUBSUTANEOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S031)Boston Scientific Corporation2014-04-29
CAMERON HEALTH SUBCUTANEOUSIMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S032)Boston Scientific Corporation2014-04-28
LD LLIAC PREMOUNTED STENT SYSTEM (P090003/S031)Boston Scientific Corporation2014-04-24
S-ICD SYSTEM (P110042/S028)Boston Scientific Corporation2014-04-15
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S017)Boston Scientific Corporation2014-04-02
S-ICD SYSTEM (P110042/S027)Boston Scientific Corporation2014-03-12
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR ( S-ICD) SYSTEM (P110042/S026)Boston Scientific Corporation2014-02-07
CAMERON HEALTH SUBCUTANCOUS IMPLANTABLE DEFIBRILLATOR S-ICD SYSTEM (P110042/S025)Boston Scientific Corporation2014-01-31
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S020)Boston Scientific Corporation2014-01-31
EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM (P090003/S030)Boston Scientific Corporation2014-01-29
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S024)Boston Scientific Corporation2014-01-22
WALLSTENT (VENOUS)ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P980033/S039)Boston Scientific Corporation2013-12-20
WALLSTENT SYSTEM (10 MM VENOUS ENDOPROSTHESIS) AND UNISTEP PLUS DELIVERY SYSTEM (12 MM VENOUS ENDOPROSTHESIS) (P980033/S040)Boston Scientific Corporation2013-12-18
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S023)Boston Scientific Corporation2013-12-16
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Every clearance here is in the API, with alerts when new ones post.