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Boston Scientific Corp

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

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RecordFirmDate
BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S038)Boston Scientific Corp2021-03-24
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S190)Boston Scientific Corp2021-03-24
REBEL Platinum Chromium Coronary Stent System (P130030/S072)Boston Scientific Corp2021-03-24
AMS 700 Inflatable Penile Prosthesis (N970012/S185)Boston Scientific Corp2021-03-16
PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S189)Boston Scientific Corp2021-03-05
ELUVIA Drug-Eluting Vascular Stent System (P180011/S041)Boston Scientific Corp2021-03-03
MetriQ Pump (P150005/S062)Boston Scientific Corp2021-03-03
Epic Self Expanding Stent System (P110035/S065)Boston Scientific Corp2021-03-03
PROMUS Everolimus-Eluting Coronary Stent System (P110010/S188)Boston Scientific Corp2021-02-24
ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S532)Boston Scientific Corp2021-02-24
WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S041)Boston Scientific Corp2021-02-10
Rotablator or ROTAPRO Rotational Atherectomy System (P900056/S183)Boston Scientific Corp2021-02-05
PROMUS Element Plus Everolimus-Eluting Coronary Stent System, Promus PREMIER Everolimus-Eluting Coronary Stent System, P (P110010/S187)Boston Scientific Corp2021-02-05
Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S259)Boston Scientific Corp2021-02-02
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S529)Boston Scientific Corp2021-02-02
Vercise Genus Deep Brain Stimulation (DBS) System (P150031/S034)Boston Scientific Corp2021-01-21
EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti (P010012/S531)Boston Scientific Corp2021-01-13
Vercise Deep Brain Stimulation (DBS) System (P150031/S028)Boston Scientific Corp2020-12-29
Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S058)Boston Scientific Corp2020-12-18
700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S184)Boston Scientific Corp2020-12-17
Epic Vascular Self-Expanding Stent System (P110035/S064)Boston Scientific Corp2020-12-17
AMS 800 Artificial Urinary Sphincter (P000053/S119)Boston Scientific Corp2020-12-17
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S040)Boston Scientific Corp2020-12-17
Eluvia Drug-Eluting Vascular Stent System (P180011/S040)Boston Scientific Corp2020-12-17
AngioJet Thrombectomy Catheter (P980037/S084)Boston Scientific Corp2020-12-17
Wolverine Coronary Cutting Balloon (P950020/S111)Boston Scientific Corp2020-12-16
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C (P110010/S185)Boston Scientific Corp2020-12-16
WATCHMAN Left Atrial Appendage Closure Device with Delivery System (P130013/S039)Boston Scientific Corp2020-12-16
Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI (P150005/S060)Boston Scientific Corp2020-12-15
ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOL (N970003/S260)Boston Scientific Corp2020-12-11
Blazer OI Catheter, IntellaNav OI Catheter, IntellaNav MiFi OI Catheter, IntellaTip MiFi OI Catheter (P150005/S059)Boston Scientific Corp2020-12-11
AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone Treatment (P000053/S118)Boston Scientific Corp2020-12-11
Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S530)Boston Scientific Corp2020-12-11
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S186)Boston Scientific Corp2020-12-08
ELUVIA Drug-Eluting Vascular Stent System (P180011/S039)Boston Scientific Corp2020-12-08
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S071)Boston Scientific Corp2020-12-08
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S525)Boston Scientific Corp2020-12-04
WaveWriter Alpha Spinal Cord Stimulator (SCS) System (P030017/S338)Boston Scientific Corp2020-12-01
Eluvia Drug-Eluting Vascular Stent System (P180011/S038)Boston Scientific Corp2020-11-30
Epic Self Expanding Stent System (P110035/S063)Boston Scientific Corp2020-11-30
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S183)Boston Scientific Corp2020-11-30
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S191)Boston Scientific Corp2020-11-23
WOLVERINE Cutting Balloon Micro-Surgical Dilation Catheter (P950020/S110)Boston Scientific Corp2020-11-20
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Coro (P110010/S184)Boston Scientific Corp2020-11-19
Express SD Renal Premounted Stent System (P060006/S102)Boston Scientific Corp2020-11-18
ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S258)Boston Scientific Corp2020-11-16
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S526)Boston Scientific Corp2020-11-12
AngioJet Rheolytic Thrombectomy System (P980037/S083)Boston Scientific Corp2020-11-12
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S527)Boston Scientific Corp2020-11-05
AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S183)Boston Scientific Corp2020-10-30
AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S117)Boston Scientific Corp2020-10-30
AngioJet Rheolytic Thrombectomy Catheter (P980037/S082)Boston Scientific Corp2020-10-29
PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG (N970003/S257)Boston Scientific Corp2020-10-22
ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN CRT-D, ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, RESONATE CR (P010012/S524)Boston Scientific Corp2020-10-22
ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult (N970003/S254)Boston Scientific Corp2020-10-22
COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT - CRT-D Resynchroniza (P010012/S522)Boston Scientific Corp2020-10-22
ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE Pacemakers (N970003/S255)Boston Scientific Corp2020-10-16
Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C (P110010/S182)Boston Scientific Corp2020-10-13
MetriQ Irrigation Tubing Set (P150005/S057)Boston Scientific Corp2020-10-09
ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S523)Boston Scientific Corp2020-10-01
PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT (N970003/S256)Boston Scientific Corp2020-10-01
Precision Montage and Precision Montage MRI Spinal Cord Stimulator Systems (P030017/S342)Boston Scientific Corp2020-09-30
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S188)Boston Scientific Corp2020-09-29
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S189)Boston Scientific Corp2020-09-29
Rotablator Rotational Atherectomy System (P900056/S190)Boston Scientific Corp2020-09-25
WOLVERINE Coronary Cutting Balloon (P950020/S109)Boston Scientific Corp2020-09-22
Precision Spinal Cord Stimulator (SCS) Systems (P030017/S341)Boston Scientific Corp2020-09-22
AMS 800 Artificial Urinary Sphincter (AUS) with InhibiZone Treatment (P000053/S116)Boston Scientific Corp2020-09-17
Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S180)Boston Scientific Corp2020-09-17
AMS 700 Inflatable Penile Prosthesis (IPP) with InhibiZone Treatment (N970012/S182)Boston Scientific Corp2020-09-16
Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus) and ROTAPRO Rotational Atherectomy System (ROTAPRO, (P900056/S187)Boston Scientific Corp2020-09-10
AMS 700 Inflatable Penile Prosthesis with and without Inhibizone Treatment (N970012/S181)Boston Scientific Corp2020-09-09
AMS 700 Inflatable Penile Prosthesis and AMS 700 Inflatable Penile Prosthesis with InhibiZone Treatment (N970012/S180)Boston Scientific Corp2020-09-04
ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 - Non MRI Pacemakers (N970003/S253)Boston Scientific Corp2020-09-03
ELUVIA Drug-Eluting Vascular Stent System (P180011/S036)Boston Scientific Corp2020-09-02
Eluvia Drug-Eluting Vascular Stent System (P180011/S037)Boston Scientific Corp2020-08-28
Epic Vascular Self-Expanding Stent System (P110035/S062)Boston Scientific Corp2020-08-28
AMS 800 Artificial Urinary Sphincter and AMS 800 Artificial Urinary Sphincter with InhibiZone Treatment (P000053/S115)Boston Scientific Corp2020-08-26
Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S181)Boston Scientific Corp2020-08-20
REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S070)Boston Scientific Corp2020-08-20
Express SD Renal Premounted Stent System (P060006/S101)Boston Scientific Corp2020-08-17
Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S038)Boston Scientific Corp2020-08-14
Vercise Deep Brain Stimulation (DBS) Systems (P150031/S036)Boston Scientific Corp2020-08-12
Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Spectra Wave Write (P030017/S340)Boston Scientific Corp2020-08-11
Vercise Deep Brain Stimulation (DBS) System and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S037)Boston Scientific Corp2020-08-11
AngioJet Rheolytic Thrombectomy Catheter (P980037/S081)Boston Scientific Corp2020-08-10
CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S521)Boston Scientific Corp2020-08-03
PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S252)Boston Scientific Corp2020-08-03
Epic Vascular Self-Expanding Stent System (P110035/S060)Boston Scientific Corp2020-07-30
AMS 800 Artificial Urinary Sphincter (P000053/S114)Boston Scientific Corp2020-07-30
AMS 700 Inflatable Penile Prosthesis and AMS Ambicor Penile Prosthesis (N970012/S179)Boston Scientific Corp2020-07-30
Eluvia Drug-Eluting Vascular Stent System (P180011/S034)Boston Scientific Corp2020-07-30
Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S068)Boston Scientific Corp2020-07-22
EPIC Self Expanding Stent System (P110035/S061)Boston Scientific Corp2020-07-22
WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System and WATCHMAN Left Atrial Appendage Closure Device (P130013/S035)Boston Scientific Corp2020-07-21
Eluvia Drug-Eluting Vascular Stent System (P180011/S035)Boston Scientific Corp2020-07-20
Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S186)Boston Scientific Corp2020-07-16
Eluvia Drug-Eluting Vascular Stent System (P180011/S033)Boston Scientific Corp2020-07-10
ACUITY X4 (P010012/S520)Boston Scientific Corp2020-07-07
REBEL Platinum Chromium Coronary Stent System Monorail and Over-the-Wire (P130030/S069)Boston Scientific Corp2020-07-01
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Every clearance here is in the API, with alerts when new ones post.