| Innova Self-Expanding Stent System (P140028/S076) | Boston Scientific Corporation | 2023-02-16 |
| Axonics Sacral Neuromodulation System (P190006/S054) | Boston Scientific Corporation | 2023-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S054) | Boston Scientific Corporation | 2023-02-07 |
| Synergy XD Everolimus-Eluting Platinum Chromium Coronary Stent System, Synergy Megatron Everolimus-Eluting Platinum Chro (P150003/S088) | Boston Scientific Corporation | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P180046/S064) | Boston Scientific Corporation | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S064) | Boston Scientific Corporation | 2023-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S056) | Boston Scientific Corporation | 2023-01-30 |
| Axonics Sacral Neuromodulation System (P180046/S056) | Boston Scientific Corporation | 2023-01-30 |
| Subcutaneous ICD Devices (P110042/S173) | Boston Scientific Corporation | 2022-12-20 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S062) | Boston Scientific Corporation | 2022-12-19 |
| Axonics Sacral Neuromodulation System (bowel) (P190006/S062) | Boston Scientific Corporation | 2022-12-19 |
| ENROUTE Transcarotid Stent System (P140026/S026) | Boston Scientific Corporation | 2022-12-16 |
| ENROUTE® Transcarotid Stent System (P140026/S025) | Boston Scientific Corporation | 2022-12-16 |
| SICD Gen 2, SICD MRI (P110042/S177) | Boston Scientific Corporation | 2022-12-14 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S174) | Boston Scientific Corporation | 2022-12-12 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S176) | Boston Scientific Corporation | 2022-12-07 |
| TheraSphere (P200029/S004) | Boston Scientific Corporation | 2022-12-02 |
| eCoin Implant Tibial Stimulator (P200036/S004) | Boston Scientific Corporation | 2022-11-30 |
| WALLSTENT Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S061) | Boston Scientific Corporation | 2022-11-28 |
| Express® LD Iliac Premounted Stent System (P090003/S053) | Boston Scientific Corporation | 2022-11-28 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S089) | Boston Scientific Corporation | 2022-11-28 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S017) | Boston Scientific Corporation | 2022-11-23 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S016) | Boston Scientific Corporation | 2022-11-15 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S015) | Boston Scientific Corporation | 2022-11-10 |
| INNOVA Vascular Self-Expanding Stent System (P140028/S075) | Boston Scientific Corporation | 2022-11-07 |
| Axonics Sacral Neuromodulation System (Urinary) (P180046/S061) | Boston Scientific Corporation | 2022-11-01 |
| Axonics Sacral Neuromodulation System (Bowel) (P190006/S061) | Boston Scientific Corporation | 2022-11-01 |
| S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S175) | Boston Scientific Corporation | 2022-10-28 |
| Bulkamid Urethral Bulking System (P170023/S012) | Boston Scientific Corporation | 2022-10-26 |
| Bulkamid Urethral Bulking System (P170023/S013) | Boston Scientific Corporation | 2022-10-26 |
| Venous Wallstent and Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S060) | Boston Scientific Corporation | 2022-10-14 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S014) | Boston Scientific Corporation | 2022-10-12 |
| ORBERA ® Intragastric Balloon (IGB) System (P140008/S024) | Boston Scientific Corporation | 2022-10-05 |
| EMBLEM S-ICD, EMBLEM MRI S ICD (P110042/S172) | Boston Scientific Corporation | 2022-09-27 |
| Axonics Sacral Neuromodulation System (P190006/S059) | Boston Scientific Corporation | 2022-09-08 |
| Axonics Sacral Neuromodulation System (P180046/S059) | Boston Scientific Corporation | 2022-09-08 |
| Axonics Sacral Neuromodulation System (P180046/S060) | Boston Scientific Corporation | 2022-09-07 |
| Axonics Sacral Neuromodulation System (P190006/S060) | Boston Scientific Corporation | 2022-09-07 |
| Innova Vascular Self-Expanding Stent System (P140028/S074) | Boston Scientific Corporation | 2022-08-29 |
| Express® LD Iliac Premounted Stent System (P090003/S052) | Boston Scientific Corporation | 2022-08-25 |
| ENROUTE Transcarotid Stent System (P140026/S023) | Boston Scientific Corporation | 2022-08-19 |
| eCoin Peripheral Neurostimulator (P200036/S001) | Boston Scientific Corporation | 2022-08-17 |
| Bulkamid Urethral Bulking System (P170023/S010) | Boston Scientific Corporation | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S009) | Boston Scientific Corporation | 2022-08-05 |
| Bulkamid Urethral Bulking System (P170023/S011) | Boston Scientific Corporation | 2022-08-05 |
| ENROUTE Transcarotid Stent System (P140026/S020) | Boston Scientific Corporation | 2022-07-20 |
| Axonics Sacral Neuromodulation System (P180046/S057) | Boston Scientific Corporation | 2022-07-20 |
| Axonics Sacral Neuromodulation System (P190006/S057) | Boston Scientific Corporation | 2022-07-20 |
| eCoin (Electroceutical Coin) (P200036/S003) | Boston Scientific Corporation | 2022-07-15 |
| SICD Gen 2 A209, SICD MRI A219 (P110042/S171) | Boston Scientific Corporation | 2022-07-13 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S059) | Boston Scientific Corporation | 2022-06-28 |
| ENROUTE® Transcarotid Stent System (P140026/S021) | Boston Scientific Corporation | 2022-06-24 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S170) | Boston Scientific Corporation | 2022-06-21 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chro (P150003/S086) | Boston Scientific Corporation | 2022-05-25 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cono (P150003/S087) | Boston Scientific Corporation | 2022-05-19 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S169) | Boston Scientific Corporation | 2022-05-18 |
| Axonics Sacral Neuromodulation System (P190006/S055) | Boston Scientific Corporation | 2022-05-13 |
| Axonics Sacral Neuromodulation System (P180046/S055) | Boston Scientific Corporation | 2022-05-13 |
| lnnova Vascular Self-Expanding Stent with Delivery System (P140028/S073) | Boston Scientific Corporation | 2022-05-06 |
| SYNERGY Drug Eluting Coronary Stent System (P150003/S085) | Boston Scientific Corporation | 2022-05-06 |
| ENROUTE Transcarotid Stent System (P140026/S019) | Boston Scientific Corporation | 2022-05-03 |
| ENROUTE Transcarotid Stent System (P140026/S016) | Boston Scientific Corporation | 2022-04-28 |
| Axonics Sacral Neuromodulation System (P180046/S052) | Boston Scientific Corporation | 2022-04-20 |
| Axonics Sacral Neuromodulation System (P190006/S052) | Boston Scientific Corporation | 2022-04-20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S084) | Boston Scientific Corporation | 2022-03-30 |
| Axonics Sacral Neuromodulation System (P180046/S038) | Boston Scientific Corporation | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P190006/S038) | Boston Scientific Corporation | 2022-03-07 |
| Axonics Sacral Neuromodulation System (P180046/S051) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S046) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P180046/S046) | Boston Scientific Corporation | 2022-03-03 |
| Axonics Sacral Neuromodulation System (P190006/S051) | Boston Scientific Corporation | 2022-03-03 |
| eCoin Peripheral Neurostimulator (P200036) | Boston Scientific Corporation | 2022-03-01 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S013) | Boston Scientific Corporation | 2022-02-25 |
| Subcutaneous ICD Devices (P110042/S167) | Boston Scientific Corporation | 2022-02-24 |
| Ranger Over-The-Wire Paclitaxel-Coated Balloon Catheter (P190019/S012) | Boston Scientific Corporation | 2022-02-22 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S083) | Boston Scientific Corporation | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P190006/S050) | Boston Scientific Corporation | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P180046/S050) | Boston Scientific Corporation | 2022-02-10 |
| Axonics Sacral Neuromodulation System (P180046/S044) | Boston Scientific Corporation | 2022-02-01 |
| Axonics Sacral Neuromodulation System (P190006/S044) | Boston Scientific Corporation | 2022-02-01 |
| Axonics Sacral Neuromodulation System (P180046/S049) | Boston Scientific Corporation | 2022-01-25 |
| Axonics Sacral Neuromodulation System (P190006/S049) | Boston Scientific Corporation | 2022-01-25 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S010) | Boston Scientific Corporation | 2022-01-18 |
| Axonics Sacral Neuromodulation System (P190006/S047) | Boston Scientific Corporation | 2022-01-14 |
| Axonics Sacral Neuromodulation System (P180046/S047) | Boston Scientific Corporation | 2022-01-14 |
| Axonics Sacral Neuromodulation System (P180046/S041) | Boston Scientific Corporation | 2022-01-04 |
| Axonics Sacral Neuromodulation System (P190006/S041) | Boston Scientific Corporation | 2022-01-04 |
| Subcutaneous Implantable Cardiac Defibrillators, Emblem MRI S-ICD, Emblem S-ICD (P110042/S166) | Boston Scientific Corporation | 2021-12-29 |
| Axonics Sacral Neuromodulation System (P190006/S045) | Boston Scientific Corporation | 2021-12-28 |
| Axonics Sacral Neuromodulation System (P180046/S045) | Boston Scientific Corporation | 2021-12-28 |
| Innova Vascular Self-Expanding Stent System (P140028/S070) | Boston Scientific Corporation | 2021-12-23 |
| SICD Gen 2, SICD MRI (P110042/S168) | Boston Scientific Corporation | 2021-12-21 |
| ORBERA® Intragastric Balloon (IGB) System (P140008/S023) | Boston Scientific Corporation | 2021-12-21 |
| EMBLEM subcutaneous implantable cardioverter defibrillation (S-ICD) Programmer, EMBLEM Pulse Generator (PG) (P110042/S164) | Boston Scientific Corporation | 2021-12-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Cor (P150003/S081) | Boston Scientific Corporation | 2021-12-17 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S080) | Boston Scientific Corporation | 2021-12-16 |
| Innova Vascular Self-Expanding Stent System (P140028/S072) | Boston Scientific Corporation | 2021-12-15 |
| Subcutaneous ICD Devices (P110042/S159) | Boston Scientific Corporation | 2021-11-30 |
| Axonics Sacral Neuromodulation System (P180046/S043) | Boston Scientific Corporation | 2021-11-22 |
| Axonics Sacral Neuromodulation System (P190006/S043) | Boston Scientific Corporation | 2021-11-22 |