| EMBLEM S-ICD pulse generator (PG) Models A209/A219 (P110042/S161) | Boston Scientific Corporation | 2021-11-16 |
| Axonics Sacral Neuromodulation System (P190006/S042) | Boston Scientific Corporation | 2021-11-15 |
| Axonics Sacral Neuromodulation System (P180046/S042) | Boston Scientific Corporation | 2021-11-15 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S036) | Boston Scientific Corporation | 2021-11-03 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S036) | Boston Scientific Corporation | 2021-11-03 |
| EMBLEM S-ICD; EMBLEM MRI S ICD (P110042/S165) | Boston Scientific Corporation | 2021-10-21 |
| EMBLEM S-ICD PG models A209 and A219. (P110042/S160) | Boston Scientific Corporation | 2021-10-19 |
| Innova Self-Expanding Stent System (P140028/S071) | Boston Scientific Corporation | 2021-10-07 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S163) | Boston Scientific Corporation | 2021-10-06 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S079) | Boston Scientific Corporation | 2021-10-04 |
| S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE (P110042/S162) | Boston Scientific Corporation | 2021-09-24 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories (P110042/S158) | Boston Scientific Corporation | 2021-09-24 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S078) | Boston Scientific Corporation | 2021-09-22 |
| EMBLEM S-ICD (P110042/S157) | Boston Scientific Corporation | 2021-09-17 |
| Axonics Sacral Neuromodulation System (P180046/S027) | Boston Scientific Corporation | 2021-09-16 |
| Axonics Sacral Neuromodulation System (P190006/S027) | Boston Scientific Corporation | 2021-09-16 |
| Innova Vascular Self-Expanding Stent System (P140028/S068) | Boston Scientific Corporation | 2021-09-13 |
| Innova Self-Expanding Stent System (P140028/S069) | Boston Scientific Corporation | 2021-09-10 |
| TheraSphere (P200029/S002) | Boston Scientific Corporation | 2021-08-19 |
| ORBERA Intragastric Balloon (IGB) System (P140008/S022) | Boston Scientific Corporation | 2021-08-12 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus-E (P150003/S077) | Boston Scientific Corporation | 2021-07-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire), SYNERGY XD Everolimus- (P150003/S076) | Boston Scientific Corporation | 2021-07-01 |
| VICI VENOUS STENT System (P180013/S007) | Boston Scientific Corporation | 2021-06-29 |
| Axonics Sacral Neuromodulation System (P180046/S025) | Boston Scientific Corporation | 2021-06-11 |
| Axonics Sacral Neuromodulation System (P190006/S025) | Boston Scientific Corporation | 2021-06-11 |
| EMBLEM S-ICD Lead (P110042/S154) | Boston Scientific Corporation | 2021-06-10 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S074) | Boston Scientific Corporation | 2021-05-27 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P180046/S037) | Boston Scientific Corporation | 2021-05-25 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P190006/S037) | Boston Scientific Corporation | 2021-05-25 |
| Axonics Sacral Neuromodulation System (P180046/S024) | Boston Scientific Corporation | 2021-05-19 |
| Axonics Sacral Neuromodulation System (P190006/S024) | Boston Scientific Corporation | 2021-05-19 |
| SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S075) | Boston Scientific Corporation | 2021-05-18 |
| TheraSphere (P200029/S001) | Boston Scientific Corporation | 2021-05-14 |
| ENROUTE® Transcarotid Stent System (P140026/S018) | Boston Scientific Corporation | 2021-05-05 |
| Express LD Iliac Premounted Stent System (P090003/S051) | Boston Scientific Corporation | 2021-04-30 |
| SICD Gen 2, SICD MRI (P110042/S156) | Boston Scientific Corporation | 2021-04-30 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S073) | Boston Scientific Corporation | 2021-04-29 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S008) | Boston Scientific Corporation | 2021-04-20 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-Tech Programmer and Related Accessories (P110042/S153) | Boston Scientific Corporation | 2021-04-02 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S155) | Boston Scientific Corporation | 2021-04-02 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S009) | Boston Scientific Corporation | 2021-04-01 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S017) | Boston Scientific Corporation | 2021-03-30 |
| LOTUS Edge Valve System (P180029/S030) | Boston Scientific Corporation | 2021-03-30 |
| Axonics Sacral Neuromodulation (SNM) System Bowel Control (P190006/S034) | Boston Scientific Corporation | 2021-03-25 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P180046/S034) | Boston Scientific Corporation | 2021-03-25 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S072) | Boston Scientific Corporation | 2021-03-24 |
| SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S071) | Boston Scientific Corporation | 2021-03-19 |
| TheraSphere (P200029) | Boston Scientific Corporation | 2021-03-17 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S033) | Boston Scientific Corporation | 2021-03-16 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S033) | Boston Scientific Corporation | 2021-03-16 |
| Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S007) | Boston Scientific Corporation | 2021-03-15 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S070) | Boston Scientific Corporation | 2021-03-05 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S032) | Boston Scientific Corporation | 2021-03-04 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S032) | Boston Scientific Corporation | 2021-03-04 |
| Innova Self Expanding Stent System (P140028/S067) | Boston Scientific Corporation | 2021-03-03 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S031) | Boston Scientific Corporation | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S031) | Boston Scientific Corporation | 2021-03-02 |
| Axonics Sacral Neuromodulation (SNM) System Urinary Control (P190006/S030) | Boston Scientific Corporation | 2021-03-01 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S030) | Boston Scientific Corporation | 2021-03-01 |
| Axonics Sacral Neuromodulation (SNM) System for Bowel Control (P180046/S029) | Boston Scientific Corporation | 2021-02-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S006) | Boston Scientific Corporation | 2021-02-24 |
| Axonics Sacral Neuromodulation (SNM) System for Urinary Control (P190006/S029) | Boston Scientific Corporation | 2021-02-23 |
| VICI VENOUS STENT System and VICI RDS Stent System (P180013/S006) | Boston Scientific Corporation | 2021-02-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S003) | Boston Scientific Corporation | 2021-02-10 |
| Axonics Sacral Neuromodulation System (P180046/S026) | Boston Scientific Corporation | 2021-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S026) | Boston Scientific Corporation | 2021-02-03 |
| Subcutaneous Implantable Defibrillator(S-ICD) System (P110042/S150) | Boston Scientific Corporation | 2021-02-02 |
| SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S054) | Boston Scientific Corporation | 2021-01-22 |
| Bulkamid Urethral Bulking System (P170023/S008) | Boston Scientific Corporation | 2021-01-14 |
| EMBLEM S-ICD Subcutaneous Electrode (P110042/S152) | Boston Scientific Corporation | 2021-01-13 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S005) | Boston Scientific Corporation | 2021-01-07 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S066) | Boston Scientific Corporation | 2020-12-17 |
| Bulkamid Urethral Bulking System (P170023/S007) | Boston Scientific Corporation | 2020-12-17 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S004) | Boston Scientific Corporation | 2020-12-16 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S068) | Boston Scientific Corporation | 2020-12-16 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S151) | Boston Scientific Corporation | 2020-12-11 |
| Innova Vascular Self-Expanding Stent System (P140028/S065) | Boston Scientific Corporation | 2020-12-08 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S069) | Boston Scientific Corporation | 2020-12-08 |
| ORBERA Intragastric Balloon System (P140008/S019) | Boston Scientific Corporation | 2020-12-02 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S001) | Boston Scientific Corporation | 2020-12-02 |
| Bulkamid Urethral Bulking System (P170023/S005) | Boston Scientific Corporation | 2020-12-02 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S148) | Boston Scientific Corporation | 2020-12-01 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S066) | Boston Scientific Corporation | 2020-11-30 |
| SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten (P150003/S067) | Boston Scientific Corporation | 2020-11-19 |
| Express LD Iliac Premounted Stent System (P090003/S050) | Boston Scientific Corporation | 2020-11-18 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S147) | Boston Scientific Corporation | 2020-11-16 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S002) | Boston Scientific Corporation | 2020-11-12 |
| LOTUS Edge Valve System (P180029/S028) | Boston Scientific Corporation | 2020-11-06 |
| Axonics Sacral Neuromodulation System (P190006/S022) | Boston Scientific Corporation | 2020-11-05 |
| S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S149) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (Bowel) (P180046/S023) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (Urinary) (P190006/S023) | Boston Scientific Corporation | 2020-11-05 |
| Axonics Sacral Neuromodulation System (P180046/S022) | Boston Scientific Corporation | 2020-11-05 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019) | Boston Scientific Corporation | 2020-10-30 |
| EMBLEM S-ICD - Subcutaneous Devices (P110042/S142) | Boston Scientific Corporation | 2020-10-22 |
| Bulkamid Urethral Bulking System (P170023/S003) | Boston Scientific Corporation | 2020-10-22 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S143) | Boston Scientific Corporation | 2020-10-16 |
| ORBERA Intragastric Balloon System (P140008/S021) | Boston Scientific Corporation | 2020-10-16 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S065) | Boston Scientific Corporation | 2020-10-13 |
| Axonics Sacral Neuromodulation System (P180046/S020) | Boston Scientific Corporation | 2020-10-09 |