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Boston Scientific Corporation

944 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
Axonics Sacral Neuromodulation System (P190006/S020)Boston Scientific Corporation2020-10-09
LOTUS Edge Valve System (P180029/S027)Boston Scientific Corporation2020-10-07
S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S146)Boston Scientific Corporation2020-10-01
Axonics Sacral Neuromodulation System (P190006/S021)Boston Scientific Corporation2020-09-21
Axonics Sacral Neuromodulation System (P180046/S021)Boston Scientific Corporation2020-09-21
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S063)Boston Scientific Corporation2020-09-17
LOTUS Edge Valve System (P180029/S026)Boston Scientific Corporation2020-09-17
EMBLEM S-ICD Programmer (P110042/S144)Boston Scientific Corporation2020-09-17
VICI VENOUS STENT System (P180013/S002)Boston Scientific Corporation2020-09-15
Subcutaneous Implantable Cardioverter Defibrillator (P110042/S145)Boston Scientific Corporation2020-09-10
VICI VENOUS STENT System (P180013/S004)Boston Scientific Corporation2020-09-03
Innova Vascular Self-Expanding Stent System (P140028/S063)Boston Scientific Corporation2020-09-02
Axonics Sacral Neuromodulation System (P180046/S015)Boston Scientific Corporation2020-08-31
Axonics Sacral Neuromodulation System (P190006/S015)Boston Scientific Corporation2020-08-31
Innova Vascular Self-Expanding Stent System (P140028/S064)Boston Scientific Corporation2020-08-28
LOTUS Edge Valve System (P180029/S025)Boston Scientific Corporation2020-08-20
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S064)Boston Scientific Corporation2020-08-20
LOTUS Edge Valve System (P180029/S020)Boston Scientific Corporation2020-08-17
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P150003/S058)Boston Scientific Corporation2020-08-10
EMBLEM S-ICD Pulse Generator (P110042/S140)Boston Scientific Corporation2020-08-06
SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S141)Boston Scientific Corporation2020-08-03
Innova Vascular Self-Expanding Stent with Delivery System (P140028/S061)Boston Scientific Corporation2020-07-30
Axonics Sacral Neuromodulation (SNM) System (P180046/S019)Boston Scientific Corporation2020-07-28
Axonics Sacral Neuromodulation (SNM) System (P190006/S019)Boston Scientific Corporation2020-07-28
EMBLEM Subcutaneous Implantable Cardioverter Defibrillator S-ICD (P110042/S139)Boston Scientific Corporation2020-07-22
Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S058)Boston Scientific Corporation2020-07-22
Axonics Sacral Neuromodulation System (P190006/S014)Boston Scientific Corporation2020-07-21
Axonics Sacral Neuromodulation System (P180046/S013)Boston Scientific Corporation2020-07-21
Innova Vascular Self-Expanding Stent System (P140028/S062)Boston Scientific Corporation2020-07-20
Axonics Sacral Neuromodulation System (P190006/S017)Boston Scientific Corporation2020-07-10
Axonics Sacral Neuromodulation System (P180046/S017)Boston Scientific Corporation2020-07-10
Axonics Sacral Neuromodulation System (P190006/S018)Boston Scientific Corporation2020-07-08
Axonics Sacral Neuromodulation System (P180046/S018)Boston Scientific Corporation2020-07-08
EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S137)Boston Scientific Corporation2020-07-07
Axonics SNM System (P190006/S016)Boston Scientific Corporation2020-07-02
Axonics SNM System (P180046/S016)Boston Scientific Corporation2020-07-02
Axonics Sacral Neuromodulation System (P190006/S011)Boston Scientific Corporation2020-07-01
Axonics Sacral Neuromodulation System (P180046/S011)Boston Scientific Corporation2020-07-01
Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S057)Boston Scientific Corporation2020-06-25
LOTUS Edge Valve System (P180029/S022)Boston Scientific Corporation2020-06-17
Innova Vascular Self-Expanding Stent System (P140028/S060)Boston Scientific Corporation2020-06-12
LOTUS Edge Valve System (P180029/S024)Boston Scientific Corporation2020-06-11
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S062)Boston Scientific Corporation2020-06-09
ENROUTE Transcarotid Stent System (P140026/S014)Boston Scientific Corporation2020-06-04
Axonics Sacral Neuromodulation System (P190006/S006)Boston Scientific Corporation2020-06-02
Bulkamid Urethral Bulking System (P170023/S001)Boston Scientific Corporation2020-06-02
Axonics Sacral Neuromodulation System (P180046/S006)Boston Scientific Corporation2020-06-02
ENROUTE Transcarotid Stent System (P140026/S015)Boston Scientific Corporation2020-06-01
SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™) (P150003/S055)Boston Scientific Corporation2020-05-28
EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) (P110042/S138)Boston Scientific Corporation2020-05-28
VICI VENOUS STENT System (P180013/S005)Boston Scientific Corporation2020-05-26
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S059)Boston Scientific Corporation2020-05-19
Innova Self-Expanding Stent System (P140028/S056)Boston Scientific Corporation2020-05-19
LOTUS Edge Valve System (P180029/S023)Boston Scientific Corporation2020-05-13
SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S061)Boston Scientific Corporation2020-05-06
Innova Vascular Self-Expanding Stent with Delivery System (P140028/S055)Boston Scientific Corporation2020-05-05
Innova Self-Expanding Stent System (P140028/S058)Boston Scientific Corporation2020-04-22
Innova Self-Expanding Stent System (P140028/S059)Boston Scientific Corporation2020-04-20
Axonics Sacral Neuromodulation (SNM) System (P180046/S004)Boston Scientific Corporation2020-04-19
Innova Vascular Self-Expanding Stent System (P140028/S053)Boston Scientific Corporation2020-04-16
Axonics Sacral Neuromodulation (SNM) System (P180046/S001)Boston Scientific Corporation2020-04-15
Axonics Sacral Neuromodulation (SNM) System (P180046/S002)Boston Scientific Corporation2020-04-15
Innova Vascular Self-Expanding Stent with Delivery System (P140028/S057)Boston Scientific Corporation2020-04-13
Axonics Sacral Neuromodulation (SNM) System (P190006/S004)Boston Scientific Corporation2020-04-13
Axonics Sacral Neuromodulation System (P190006/S010)Boston Scientific Corporation2020-04-10
Axonics Sacral Neuromodulation System (P180046/S010)Boston Scientific Corporation2020-04-10
Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S060)Boston Scientific Corporation2020-04-09
Axonics Sacral Neuromodulation System (P190006/S009)Boston Scientific Corporation2020-04-07
Axonics Sacral Neuromodulation System (P180046/S009)Boston Scientific Corporation2020-04-07
S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S136)Boston Scientific Corporation2020-04-07
Axonics Sacral Neuromodulation System (P190006/S008)Boston Scientific Corporation2020-04-03
Axonics Sacral Neuromodulation System (P180046/S007)Boston Scientific Corporation2020-04-03
Axonics Sacral Neuromodulation System (P180046/S008)Boston Scientific Corporation2020-04-03
Axonics Sacral Neuromodulation System (P190006/S007)Boston Scientific Corporation2020-04-03
Subcutaneous ICD Devices: EMBLEM S-ICD (P110042/S133)Boston Scientific Corporation2020-04-01
EMBLEM S-ICD System (P110042/S132)Boston Scientific Corporation2020-03-20
VENOUS WALLSTENT (P980033/S050)Boston Scientific Corporation2020-03-17
SICD Gen 2 and SICD MRI (P110042/S135)Boston Scientific Corporation2020-03-17
LOTUS Edge Valve System (P180029/S021)Boston Scientific Corporation2020-03-11
S-ICD GEN and S-ICD EMBLEM MRI (P110042/S134)Boston Scientific Corporation2020-03-05
Express LD Premounted Iliac Stent System (P090003/S049)Boston Scientific Corporation2020-03-02
Axonics Sacral Neuromodulation (SNM) System (P190006/S005)Boston Scientific Corporation2020-02-28
Axonics Sacral Neuromodulation (SNM) System (P180046/S005)Boston Scientific Corporation2020-02-28
Innova Vascular Self-Expanding Stent System (P140028/S054)Boston Scientific Corporation2020-02-20
ORBERA Intragastric Balloon System (P140008/S016)Boston Scientific Corporation2020-02-13
Axonics Sacral Neuromodulation (SNM) System (P180046/S003)Boston Scientific Corporation2020-01-30
Bulkamid Urethral Bulking System (P170023)Boston Scientific Corporation2020-01-28
Axonics Sacral Neuromodulation (SNM) System (P190006/S003)Boston Scientific Corporation2020-01-28
Axonics Sacral Neuromodulation (SNM) System (P190006/S001)Boston Scientific Corporation2020-01-14
Innova Vascular Self-Expanding Stent with Delivery System (P140028/S051)Boston Scientific Corporation2019-12-19
Emblem Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S131)Boston Scientific Corporation2019-12-19
Innova Vascular Self-Expanding Stent System (P140028/S050)Boston Scientific Corporation2019-12-18
LOTUS Edge Valve System (P180029/S018)Boston Scientific Corporation2019-12-17
EMBLEM S-ICD Automated Screening Tool (P110042/S129)Boston Scientific Corporation2019-12-16
Innova Vascular Self-Expanding Stent System (P140028/S052)Boston Scientific Corporation2019-12-13
Axonics Sacral Neuromodulation System (P190006/S002)Boston Scientific Corporation2019-12-12
Lotus Edge Valve System (P180029/S019)Boston Scientific Corporation2019-12-11
Lotus Edge Valve System (P180029/S003)Boston Scientific Corporation2019-12-06
Innova Vascular Self-Expanding Stent System (P140028/S049)Boston Scientific Corporation2019-12-04
Innova Self-Expanding Stent System (P140028/S047)Boston Scientific Corporation2019-12-04
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Every clearance here is in the API, with alerts when new ones post.