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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/S152)Boston Scientific Corp2014-08-26
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S002)Boston Scientific Corp2014-08-19
ACUITY SPIRAL, EASYTRAK 2 LV-1, EASYTRAK 2 IS-1, EASYTRAK 3 LV-1, EASYTRAK 3 IS-1 (P010012/S365)Boston Scientific Corp2014-08-15
NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S (P010012/S366)Boston Scientific Corp2014-08-13
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S198)Boston Scientific Corp2014-08-06
PROMUS ELEMENT PLUS/ PREMIER EVEROLIMUS- ELUTING PLATINUN CHROMIUM CORONARY STENT SYSTEM (P110010/S091)Boston Scientific Corp2014-08-05
ION PACLITITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S103)Boston Scientific Corp2014-08-05
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S001)Boston Scientific Corp2014-08-04
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S142)Boston Scientific Corp2014-08-01
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (ROTABLATOR CONSOLE AND FOOT PEDAL) (P900056/S132)Boston Scientific Corp2014-08-01
CONTAK CD, EASYTRAK, LIVIAN, COGNIS, ACUITY SPIRAL, ENERGEN, PUNCTUA, & INCEPTA CRT-D'S (P010012/S363)Boston Scientific Corp2014-07-30
PULSAR, PULSAR MAX, INSIGNIA, ALTRUA, ADVANTIO & INGENIO PACEMAKERS (N970003/S166)Boston Scientific Corp2014-07-30
DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D (P010012/S364)Boston Scientific Corp2014-07-28
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S140)Boston Scientific Corp2014-07-24
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S083)Boston Scientific Corp2014-07-18
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S063)Boston Scientific Corp2014-07-18
COGNIS, PROGENY CRT-D AND NG CRT-D MODELS (P010012/S355)Boston Scientific Corp2014-07-16
NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4 (P010012/S360)Boston Scientific Corp2014-07-11
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S200)Boston Scientific Corp2014-07-11
EASYTRAK 2 IS-1 CORONARY VENOUS BIPOLAR PACE/SENSE LEADS (P010012/S362)Boston Scientific Corp2014-07-09
INCEPTA, ENERGEN, PUCTUA, COGNIS, DYANAGEN, INOGEN, ORIGEN CRT-DS (P010012/S358)Boston Scientific Corp2014-07-08
PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS (P010012/S361)Boston Scientific Corp2014-07-08
INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS (N970003/S165)Boston Scientific Corp2014-07-08
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTINGPLATINUM CHROMIUM CORONARY STENT SYSTEM PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM (P110010/S088)Boston Scientific Corp2014-06-30
ION (TAXUS ELEMENT) PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S101)Boston Scientific Corp2014-06-30
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S061)Boston Scientific Corp2014-06-30
CHILLI II COOLED ABLATION CATHETER (P980003/S051)Boston Scientific Corp2014-06-27
ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER (P080032/S015)Boston Scientific Corp2014-06-17
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS)SYSTEM (P030017/S191)Boston Scientific Corp2014-06-17
DYNAGEN, INOGEN, ORIGEN (P010012/S357)Boston Scientific Corp2014-06-17
AMS 800 ARTIFICIAL URINARY SPHINCTER (P000053/S050)Boston Scientific Corp2014-06-16
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S199)Boston Scientific Corp2014-06-06
PRECISION SPINAL CORD STIMULATION (SCS) SYSTEM (P030017/S197)Boston Scientific Corp2014-06-06
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S086)Boston Scientific Corp2014-06-04
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S100)Boston Scientific Corp2014-06-04
BARD ABLATION SYSTEM (P000020/S017)Boston Scientific Corp2014-06-04
PRECISION SPECTRA SYSTEM (P030017/S196)Boston Scientific Corp2014-06-04
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S099)Boston Scientific Corp2014-06-03
PROMUS PREMIER & PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S087)Boston Scientific Corp2014-06-03
DYNAGEN, INOGEN, ORIGEN NG3 CARDIAC RESYNCHRONIZATION THERAPY DEFUBRILLATION DEFIBRILLATOR (CRT-D) (P010012/S356)Boston Scientific Corp2014-06-02
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD (P920047/S070)Boston Scientific Corp2014-05-30
ADVANTIO PACEMAKERS, INGENIO PACEMAKERS, VITALIO PACEMAKERS, FORMIO PACEMAKERS (N970003/S163)Boston Scientific Corp2014-05-28
PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-D,ORIGEN CRT-DS,DYNAGEN CRT-D (P010012/S353)Boston Scientific Corp2014-05-28
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S027)Boston Scientific Corp2014-05-23
INGENIO,ADVANTIO,VITALIO,FORMIO IMPLANTABLE PULSE GENERATORS (N970003/S164)Boston Scientific Corp2014-05-23
WALLSTENT TIPS ENDOPROSTHESIS (P930031/S052)Boston Scientific Corp2014-05-23
DYNAGEN,INOGEN,ORIGEN CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) (P010012/S354)Boston Scientific Corp2014-05-23
PRECISION SPECTRA SPINAL STIMULATOR (SCS) SYSTEM (P030017/S186)Boston Scientific Corp2014-05-22
ION PACLITAXEL-ELUTING PLATNIUM CHROMIUM CORONARY STENT SYSTEM (P100023/S097)Boston Scientific Corp2014-05-22
PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS (P110010/S084)Boston Scientific Corp2014-05-22
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S080)Boston Scientific Corp2014-05-19
BARD ABLATION SYSTEM (P000020/S018)Boston Scientific Corp2014-05-16
ADVANTIO, INGENIO PG FAMILIES (N970003/S160)Boston Scientific Corp2014-05-15
COGNIS CRT-D FAMILY (P010012/S349)Boston Scientific Corp2014-05-15
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S025)Boston Scientific Corp2014-05-14
INVIVE AND INTUA CARDIAC RESYNCHRONIZATION THERAPY-PACEMAKERS (CRT-P) (P010012/S351)Boston Scientific Corp2014-05-12
ADVANTIO, INGENIO, VITALIO AND FORMIO IMPLANTABLE PULSE GENERATOR (PG) (N970003/S162)Boston Scientific Corp2014-05-12
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING CORONARY STENT SYSTEM (P110010/S082)Boston Scientific Corp2014-05-12
CONTAK CD CRT-D &EASYTRAK CORONARY VENOUS STEROID ELUTING SINGLE ELCTRODE PACE/SENSE LEAD (P010012/S352)Boston Scientific Corp2014-05-07
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S138)Boston Scientific Corp2014-05-05
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S194)Boston Scientific Corp2014-05-02
PULSAR, PULSAR MAX, DISCOVER, INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO FAMILIES OF PACEMAKER (N970003/S159)Boston Scientific Corp2014-05-02
VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS (P010012/S347)Boston Scientific Corp2014-05-02
PRECISSION SPINAL CORD SIMULATOR (SCS) SYSTEM (P030017/S195)Boston Scientific Corp2014-05-02
PROMUS ELEMENT PLUS/PROMUS PREMIER EVEROLIMUS-ELUTING PALTINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIR (P110010/S080)Boston Scientific Corp2014-05-01
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S059)Boston Scientific Corp2014-05-01
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S137)Boston Scientific Corp2014-05-01
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER-THE-WIRE) (P100023/S095)Boston Scientific Corp2014-05-01
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S069)Boston Scientific Corp2014-05-01
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S079)Boston Scientific Corp2014-05-01
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S094)Boston Scientific Corp2014-05-01
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S049)Boston Scientific Corp2014-05-01
PUNCTUA, COGNIS, ENERGY, & INCEPTA CRT-D'S (P010012/S350)Boston Scientific Corp2014-05-01
ADVANTIO, INGENIO, VITALIO AND FORMIO PACEMAKERS (N970003/S161)Boston Scientific Corp2014-04-29
PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S096)Boston Scientific Corp2014-04-24
ACUITY SPIRAL, EASYTRAK 2, EASYTRAK 3 (P010012/S345)Boston Scientific Corp2014-04-24
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S136)Boston Scientific Corp2014-04-24
PROMUS ELEMENT PLUS PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S081)Boston Scientific Corp2014-04-24
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S048)Boston Scientific Corp2014-04-23
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S058)Boston Scientific Corp2014-04-23
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S068)Boston Scientific Corp2014-04-23
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S078)Boston Scientific Corp2014-04-23
ROTABLATOR RATATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S135)Boston Scientific Corp2014-04-23
ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM (P100023/S093)Boston Scientific Corp2014-04-23
PRECISION AND PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEMS (P030017/S193)Boston Scientific Corp2014-04-21
ION PACLITAXEL-ELUTING PLATINUM CHROMINUM CORONARY STENT SYSTEM OVER THE WIRE (P100023/S092)Boston Scientific Corp2014-04-17
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S192)Boston Scientific Corp2014-04-17
ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM (P900056/S134)Boston Scientific Corp2014-04-17
DYNAGEN & DYNAGEN X4 CRT-D'S; INOGEN & INOGEN X4 CRT-D'S; ORIGEN & ORIGEN X4 CRT-D'S; COGNIS CRT-D (P010012/S341)Boston Scientific Corp2014-04-11
ION PACLITAXEL-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P100023/S091)Boston Scientific Corp2014-04-11
BLAZER II, BLAZER II HTD, BLAZER PRIME HTD TEMPERATURE ABLATION CATHETERS (P920047/S067)Boston Scientific Corp2014-04-04
INCEPTA,ENERGEN,PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY HIGH ENERGY DEFIBRILLATORS (P010012/S348)Boston Scientific Corp2014-03-31
CHILLI II COOLED ABLATION CATHETER AND CABLE (P980003/S047)Boston Scientific Corp2014-03-26
ION PACLITAXEL -ELUTING CORONARY STENT SYSTEM (P100023/S089)Boston Scientific Corp2014-03-26
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S066)Boston Scientific Corp2014-03-26
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE (P900056/S133)Boston Scientific Corp2014-03-26
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S056)Boston Scientific Corp2014-03-26
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING STENT SYSTEM (P110010/S077)Boston Scientific Corp2014-03-26
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S057)Boston Scientific Corp2014-03-25
ION (TAXUS ELEMENT) CORONARY STENT SYSTEM (P100023/S090)Boston Scientific Corp2014-03-25
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Every clearance here is in the API, with alerts when new ones post.