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Boston Scientific Corp

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

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RecordFirmDate
Precision Spectra & Novi Spinal Cord Stimulator (SCS) Systems; Precision Montage MRI and Precision Montage Spinal Cord S (P030017/S257)Boston Scientific Corp2016-09-29
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S004)Boston Scientific Corp2016-09-27
WOLVERINE CORONARY CUTTING BALLOON MONORAIL, OVER-THE WIRE. (P950020/S075)Boston Scientific Corp2016-09-27
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S023)Boston Scientific Corp2016-09-27
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S030)Boston Scientific Corp2016-09-27
PRECISION, PRECISION SPECTRA AND PRECISION NOVI SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S256)Boston Scientific Corp2016-09-16
Ingenio 2 Pacemakers, ALTURA 2, ESSENTIO, PROPONENT, ACCOLADE MODEL'S (N970003/S193)Boston Scientific Corp2016-09-13
NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT); DYNAGEN. INOGEN, ORIGEN CRT-D & X4 CRT-D (P010012/S431)Boston Scientific Corp2016-09-13
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S123)Boston Scientific Corp2016-09-09
ACUITY X4 Drug Collar Component Dwell Time (P010012/S430)Boston Scientific Corp2016-09-01
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S037)Boston Scientific Corp2016-08-30
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S028)Boston Scientific Corp2016-08-30
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE TREATMENT (P000053/S065)Boston Scientific Corp2016-08-30
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S078)Boston Scientific Corp2016-08-30
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S027)Boston Scientific Corp2016-08-29
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S132)Boston Scientific Corp2016-08-29
WALLSTENT ENDOPROSTHESIS (TIPS) (P930031/S056)Boston Scientific Corp2016-08-24
ACUITY X4 STRAIGHT, ACUITY X4 SPIRAL S, ACUITY X4 SPIRAL L Quadripolar Coronary Venous Pace/Sense Leads (P010012/S423)Boston Scientific Corp2016-08-23
Dynagen & X4, Inogen & X4, Origen & X4 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (P010012/S427)Boston Scientific Corp2016-08-19
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S131)Boston Scientific Corp2016-08-19
CHILLI II (P980003/S069)Boston Scientific Corp2016-08-19
BLAZER OI; INTELLANAV OI (P150005/S010)Boston Scientific Corp2016-08-19
ANGIOJET ULTRA XMI, SPIROFLEX, SPIROFLEX VG, DISTAFLEX THROMBECTOMY SET'S (P980037/S058)Boston Scientific Corp2016-08-18
WOLVERINE CORONARY CUTTING BALLOON (MONORAIL & OVER-THE-WIRE) (P950020/S072)Boston Scientific Corp2016-08-18
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S130)Boston Scientific Corp2016-08-18
PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S241)Boston Scientific Corp2016-08-16
EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM (P060006/S077)Boston Scientific Corp2016-08-11
BLAZER II CARDIAC ABLATION CATHETER AND CABLE (P920047/S094)Boston Scientific Corp2016-08-11
BLAZER OPEN-IRRIGATED TEMPERATURE ABLATION CATHETER (P150005/S009)Boston Scientific Corp2016-08-11
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S075)Boston Scientific Corp2016-08-11
CHILLI COOLED ABLATION CATHETER AND CABLE (P980003/S068)Boston Scientific Corp2016-08-11
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S036)Boston Scientific Corp2016-08-11
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM Monorail & OTW (P130030/S025)Boston Scientific Corp2016-08-10
CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S025)Boston Scientific Corp2016-08-10
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S026)Boston Scientific Corp2016-08-10
EXPRESS SD RENAL PREMOUNTED STENT SYSTEM (P060006/S076)Boston Scientific Corp2016-08-10
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S129)Boston Scientific Corp2016-08-10
ROTABLATOR Rotational Atherectomy System (P900056/S154)Boston Scientific Corp2016-08-10
ALTRUA, ESSENTIO, PROPONENT, ACCOLADE PACEMAKERS (N970003/S192)Boston Scientific Corp2016-08-10
PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S128)Boston Scientific Corp2016-08-10
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S009)Boston Scientific Corp2016-08-04
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE (N970012/S117)Boston Scientific Corp2016-08-03
AMS 800 URINARY CONTROL SYSTEM WITH INHIBIZONE (P000053/S066)Boston Scientific Corp2016-08-03
ESSENTIO, PROPONENT, ACCOLADE,ALTRUA 2 PACEMAKER'S (N970003/S191)Boston Scientific Corp2016-08-02
ACUITY X4 STRAIGHT, SPIRAL, SPIRAL L ; DYNAGEN, INOGEN, ORIGEN CRT-D'S (P010012/S428)Boston Scientific Corp2016-08-02
DYNAGEN™ CRT-D: G150, G151, G154; DYNAGEN™ X4 CRT-D: G156, G158; INOGEN™ CRT-D: G140, G141; INOGEN™ X4 CRT-D: G146, G148 (P010012/S429)Boston Scientific Corp2016-08-01
PRECISION, SPECTRA, NOVI, SPINAL CORD STIMULATION(SCS) SYSTEM; PRECISION MONTAGE MRI AND MONTAGE SPINAL CORD STIMULATOR (P030017/S254)Boston Scientific Corp2016-07-29
PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S245)Boston Scientific Corp2016-07-28
PRECISION SPINAL CORD, SPECTRA, NOVI, MONTAGE MRI & PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEMS (P030017/S253)Boston Scientific Corp2016-07-28
ACUITY SPIRAL LEAD, ACUITY X4 LEAD (P010012/S425)Boston Scientific Corp2016-07-25
Dynagen™ Models: G150, G151, G154, G156, G158; Inogen™ Models: G140, G141, G146, G148; Origen™ (P010012/S426)Boston Scientific Corp2016-07-22
EPIC VASCULAR SELF-EXPANDING STENT SYSTEM (P110035/S034)Boston Scientific Corp2016-07-20
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S122)Boston Scientific Corp2016-07-15
EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S074)Boston Scientific Corp2016-07-13
INGEVITY LEAD (P010012/S420)Boston Scientific Corp2016-07-13
CRT-D RESYNCHRONIZATION DEVICES, COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN (P010012/S417)Boston Scientific Corp2016-07-08
PACEMAKER DEVICES. ADVANTION, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 SUPPORTED (N970003/S187)Boston Scientific Corp2016-07-08
BLAZER II, BLAZER II HTD TEMPERATURE ABLATION CATHETERS, BLAZER II XP, BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS (P920047/S092)Boston Scientific Corp2016-07-07
INTELLANAV OPEN-IRRIGATED ABLATION CATHETER (P150005/S005)Boston Scientific Corp2016-07-07
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S001)Boston Scientific Corp2016-07-05
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S006)Boston Scientific Corp2016-07-05
AMS 700 INFLATABLE PENILE PROSTHESIS (IPP) WITH INHIBIZONE TREATMENT (N970012/S116)Boston Scientific Corp2016-06-30
AMS 800 ARTIFICIAL URINARY SPHINCTER WITH INHIBIZONE TREATMENT (P000053/S064)Boston Scientific Corp2016-06-30
PRECISION NOVI SPINAL CORD STIMULATOR (SCS) SYSTEM (P030017/S252)Boston Scientific Corp2016-06-29
WATCHMAN LEFT ATRIAL APPENDAGE CLOSURE (LAAC) DEVICE (P130013/S010)Boston Scientific Corp2016-06-28
Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S091)Boston Scientific Corp2016-06-23
Contak CD, Contak Renewal, Livian ICD Families; EasyTrak, Acuity Spiral Lead Families; Cognis, Energen, Incepta, Origen, (P010012/S422)Boston Scientific Corp2016-06-23
CHILLI COOLED RF ABLATION SYSTEM (P980003/S066)Boston Scientific Corp2016-06-23
BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S007)Boston Scientific Corp2016-06-23
Ingenio™ 2 Pacemakers; ALTRUA 2™ Models: S701, S702, S722; ESSENTIO™ Models: L100, L101, L121; PROPONENT™ Models: L200, (N970003/S190)Boston Scientific Corp2016-06-20
DYNAGEN ™ CRT-D: G150, G151, G154 DYNAGEN ™ X4 CRT-D: G156, G158; INOGEN ™ CRT-D: G140, G141 INOGEN ™ X4 CRT-D: G146, G1 (P010012/S421)Boston Scientific Corp2016-06-20
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM AND PROMUS PREMIER EVEROLIMUS-ELUTING PLA (P110010/S126)Boston Scientific Corp2016-06-16
ACUITY X4 (Straight,Spiral S, Spiral L) Steroid-eluting, Coronary Venous, QUADRIPOLAR ACE/SENSE LEADS (P010012/S416)Boston Scientific Corp2016-06-09
FLEXTOME CUTTING BALLOON MICROSURGICAL DILITATION DEVICE (P950020/S073)Boston Scientific Corp2016-06-09
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S250)Boston Scientific Corp2016-06-08
PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S251)Boston Scientific Corp2016-06-07
AMS 700 INFLATABLE PENILE PROSTHESES (IPP) (N970012/S115)Boston Scientific Corp2016-05-31
AMS 800 URINARY CONTROL SYSTEM (AUS) (P000053/S063)Boston Scientific Corp2016-05-31
ADVANTIO, INGENIO, VITALIO, ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S188)Boston Scientific Corp2016-05-25
INGENIO 2 PACEMAKERS. ALTRUA 2 , ESSENTIO, PROPONENT, ACCOLADE. IMPLANTABLE PULSE GENERATOR (PG), ADVANTIO, INGENIO, VI (N970003/S189)Boston Scientific Corp2016-05-25
NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D). DYNAGEN CRT-D, X4 CRT-D; INOGEN CRT-D, X4 CRT-D; ORIGEN CRT (P010012/S419)Boston Scientific Corp2016-05-25
Rotablator Rotational Atherectomy System (ROTAWIRE GUIDEWIRE WITH WIRECLIP TORQUER) (P900056/S153)Boston Scientific Corp2016-05-25
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S125)Boston Scientific Corp2016-05-20
NG3 CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR (CRT-D) DYNAGEN CRT-D: G150, G151, G154, X4 CRT-D; G156, G158 INOGEN (P010012/S418)Boston Scientific Corp2016-05-17
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S024)Boston Scientific Corp2016-05-10
PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S124)Boston Scientific Corp2016-05-10
Dynagen, Inogen, Origen CRT-D; Dynagen, Inogen, Origen X4 CRT-D (P010012/S415)Boston Scientific Corp2016-05-09
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S007)Boston Scientific Corp2016-05-05
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S186)Boston Scientific Corp2016-05-03
WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE DEVICE (P130013/S008)Boston Scientific Corp2016-05-03
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S411)Boston Scientific Corp2016-05-03
ACUITY SPIRAL LEAD MODELS (P010012/S407)Boston Scientific Corp2016-04-29
PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM, PRECISION MONTAGE SPINAL CORD STIMULATOR SYSTEM (P030017/S235)Boston Scientific Corp2016-04-28
BLAZER PRIME HTD,BLAZER II,BLAZER II HTD TEMPERATURE ABLATION CATHETERS (P920047/S088)Boston Scientific Corp2016-04-28
ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S057)Boston Scientific Corp2016-04-22
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S413)Boston Scientific Corp2016-04-20
REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (P130030/S019)Boston Scientific Corp2016-04-19
PROMUS PREMIER EVEROLIMUS-ELUTING PLANTINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S118)Boston Scientific Corp2016-04-19
BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S073)Boston Scientific Corp2016-04-19
Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S414)Boston Scientific Corp2016-04-14
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