| Axonics Sacral Neuromodulation System (P190006/S101) | Boston Scientific Corporation | 2025-12-19 |
| Axonics Sacral Neuromodulation System (P180046/S101) | Boston Scientific Corporation | 2025-12-19 |
| SYNERGYTM Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S110) | Boston Scientific Corporation | 2025-10-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S084) | Boston Scientific Corporation | 2025-10-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S039) | Boston Scientific Corporation | 2025-10-24 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S007) | Boston Scientific Corporation | 2025-10-24 |
| ENROUTE® Transcarotid Stent System (P140026/S032) | Boston Scientific Corporation | 2025-10-23 |
| A209 SICD Gen 2,A219 SICD MRI (P110042/S206) | Boston Scientific Corporation | 2025-10-22 |
| eCoin Tibial Nerve Stimulator System (P200036/S009) | Boston Scientific Corporation | 2025-10-02 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S205) | Boston Scientific Corporation | 2025-09-16 |
| POLARx Cryoablation System (P220032/S011) | Boston Scientific Corporation | 2025-08-14 |
| lnnova Vascular Self Expanding Stent (P140028/S083) | Boston Scientific Corporation | 2025-08-08 |
| eCoin Peripheral Neurostimulator (P200036/S008) | Boston Scientific Corporation | 2025-07-16 |
| Orbera® Intragastric Balloon (IGB) System (P140008/S027) | Boston Scientific Corporation | 2025-07-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S038) | Boston Scientific Corporation | 2025-06-26 |
| Bulkamid Urethral Bulking System (P170023/S021) | Boston Scientific Corporation | 2025-05-22 |
| Bulkamid Urethral Bulking System (P170023/S022) | Boston Scientific Corporation | 2025-05-20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System; SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S109) | Boston Scientific Corporation | 2025-04-18 |
| Axonics Sacral Neuromodulation System (P180046/S098) | Boston Scientific Corporation | 2025-04-11 |
| Axonics Sacral Neuromodulation System (P190006/S098) | Boston Scientific Corporation | 2025-04-11 |
| SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S108) | Boston Scientific Corporation | 2025-04-03 |
| Axonics Sacral Neuromodulation System (P190006/S089) | Boston Scientific Corporation | 2025-04-02 |
| Axonics Sacral Neuromodulation System (P180046/S089) | Boston Scientific Corporation | 2025-04-02 |
| Boston Scientific Cardiac Cryoablation System (P220032/S010) | Boston Scientific Corporation | 2025-03-21 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S003) | Boston Scientific Corporation | 2025-03-09 |
| Bulkamid Urethral Bulking System (P170023/S020) | Boston Scientific Corporation | 2025-03-05 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S037) | Boston Scientific Corporation | 2025-02-12 |
| SMARTFREEZE Cryo-Cable (P220032/S009) | Boston Scientific Corporation | 2025-02-10 |
| Axonics Sacral Neuromodulation System (P190006/S097) | Boston Scientific Corporation | 2025-02-07 |
| Axonics Sacral Neuromodulation System (P180046/S097) | Boston Scientific Corporation | 2025-02-07 |
| SYNERGYXD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chr (P150003/S107) | Boston Scientific Corporation | 2025-02-05 |
| Axonics Sacral Neuromodulation System (P190006/S094) | Boston Scientific Corporation | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P180046/S094) | Boston Scientific Corporation | 2025-02-03 |
| Axonics Sacral Neuromodulation System (P190006/S079) | Boston Scientific Corporation | 2025-01-27 |
| Axonics Sacral Neuromodulation System (P180046/S079) | Boston Scientific Corporation | 2025-01-27 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System, SYNERGY SHIELD Everolimus Eluting Platinum Chromi (P150003/S105) | Boston Scientific Corporation | 2025-01-27 |
| Axonics Sacral Neuromodulation System (P180046/S096) | Boston Scientific Corporation | 2025-01-21 |
| Axonics Sacral Neuromodulation System (P190006/S096) | Boston Scientific Corporation | 2025-01-21 |
| Axonics Sacral Neuromodulation System (P190006/S095) | Boston Scientific Corporation | 2025-01-16 |
| Axonics Sacral Neuromodulation System (P180046/S095) | Boston Scientific Corporation | 2025-01-16 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S005) | Boston Scientific Corporation | 2025-01-14 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S036) | Boston Scientific Corporation | 2025-01-14 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Co (P150003/S106) | Boston Scientific Corporation | 2025-01-14 |
| Axonics Sacral Neuromodulation System (P190006/S084) | Boston Scientific Corporation | 2025-01-02 |
| Axonics Sacral Neuromodulation System (P180046/S084) | Boston Scientific Corporation | 2025-01-02 |
| ENROUTE® Transcarotid Stent System (P140026/S031) | Boston Scientific Corporation | 2024-12-18 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System and SYNERGY SHIELD Everolimus Eluting Platinum Chr (P150003/S100) | Boston Scientific Corporation | 2024-12-18 |
| INNOVA Self Expanding Stent System (P140028/S082) | Boston Scientific Corporation | 2024-12-17 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S034) | Boston Scientific Corporation | 2024-12-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S031) | Boston Scientific Corporation | 2024-12-11 |
| Axonics Sacral Neuromodulation System (P190006/S093) | Boston Scientific Corporation | 2024-11-27 |
| Axonics Sacral Neuromodulation System (P180046/S093) | Boston Scientific Corporation | 2024-11-27 |
| Innova Vascular Self Expanding Stent with Delivery System (P140028/S081) | Boston Scientific Corporation | 2024-11-26 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S201) | Boston Scientific Corporation | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P190006/S092) | Boston Scientific Corporation | 2024-11-25 |
| Axonics Sacral Neuromodulation System (P180046/S092) | Boston Scientific Corporation | 2024-11-25 |
| Bulkamid Urethral Bulking System (P170023/S019) | Boston Scientific Corporation | 2024-11-19 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S032) | Boston Scientific Corporation | 2024-11-07 |
| EMBLEM S-ICD ELECTRODE 45 CM 3501 (P110042/S200) | Boston Scientific Corporation | 2024-11-07 |
| Axonics Sacral Neuromodulation System (P180046/S091) | Boston Scientific Corporation | 2024-11-05 |
| Axonics Sacral Neuromodulation System (P190006/S091) | Boston Scientific Corporation | 2024-11-05 |
| ENROUTE® Transcarotid Stent System (P140026/S030) | Boston Scientific Corporation | 2024-10-25 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S199) | Boston Scientific Corporation | 2024-10-23 |
| Axonics Sacral Neuromodulation System (P180046/S090) | Boston Scientific Corporation | 2024-10-21 |
| Axonics Sacral Neuromodulation System (P190006/S090) | Boston Scientific Corporation | 2024-10-21 |
| SMARTFREEZETM Catheter Extension Cable (P220032/S004) | Boston Scientific Corporation | 2024-10-18 |
| SYNERGY SHIELD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System, YNERGY MEGATRON Monorail Everolimu (P150003/S102) | Boston Scientific Corporation | 2024-10-01 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Pulse Generator (PG) (P110042/S198) | Boston Scientific Corporation | 2024-09-25 |
| TheraSphere (P200029/S010) | Boston Scientific Corporation | 2024-09-24 |
| Axonics Sacral Neuromodulation System (P180046/S088) | Boston Scientific Corporation | 2024-09-18 |
| Axonics Sacral Neuromodulation System (P190006/S088) | Boston Scientific Corporation | 2024-09-18 |
| Axonics Sacral Neuromodulation System (P180046/S080) | Boston Scientific Corporation | 2024-09-16 |
| Axonics Sacral Neuromodulation System (P190006/S080) | Boston Scientific Corporation | 2024-09-16 |
| POLARx and POLARxFIT Cryoablation Catheters (P220032/S008) | Boston Scientific Corporation | 2024-09-12 |
| Axonics Sacral Neuromodulation System (P190006/S087) | Boston Scientific Corporation | 2024-09-04 |
| Axonics Sacral Neuromodulation System (P180046/S087) | Boston Scientific Corporation | 2024-09-04 |
| Bulkamid Urethral Bulking System (P170023/S018) | Boston Scientific Corporation | 2024-09-03 |
| POLARx FIT Cryoablation Balloon Catheters (P220032/S007) | Boston Scientific Corporation | 2024-08-23 |
| SYNERGY , SYNERGY XD, SYNERGY MEGATRON and SYNERGY Shield Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S104) | Boston Scientific Corporation | 2024-08-16 |
| EMBLEM SICD Lead (P110042/S197) | Boston Scientific Corporation | 2024-08-15 |
| Axonics Sacral Neuromodulation System (P180046/S078) | Boston Scientific Corporation | 2024-08-02 |
| Axonics Sacral Neuromodulation System (P190006/S078) | Boston Scientific Corporation | 2024-08-02 |
| Bulkamid Urethral Bulking System (P170023/S017) | Boston Scientific Corporation | 2024-07-30 |
| POLARx Short Tip (ST) Cryoablation Balloon Catheter, POLARx Long Tip (LT) Cryoablation Balloon Catheter, POLARx FIT S (P220032/S005) | Boston Scientific Corporation | 2024-07-30 |
| SYNERGY, XD, SHIELD and MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S101) | Boston Scientific Corporation | 2024-07-26 |
| Axonics Sacral Neuromodulation System (P180046/S086) | Boston Scientific Corporation | 2024-07-25 |
| Axonics Sacral Neuromodulation System (P190006/S086) | Boston Scientific Corporation | 2024-07-25 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S033) | Boston Scientific Corporation | 2024-07-23 |
| Latitude NXT Patient Management System (EMBLEM S-ICD) (P110042/S195) | Boston Scientific Corporation | 2024-07-18 |
| Axonics Sacral Neuromodulation System (P190006/S085) | Boston Scientific Corporation | 2024-07-16 |
| Synergy Everolimus-eluting Platinum Chromium Coronary Stent System (P150003/S099) | Boston Scientific Corporation | 2024-07-16 |
| Axonics Sacral Neuromodulation System (P180046/S085) | Boston Scientific Corporation | 2024-07-16 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S006) | Boston Scientific Corporation | 2024-07-05 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S002) | Boston Scientific Corporation | 2024-06-28 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S066) | Boston Scientific Corporation | 2024-06-27 |
| ORBERA Intragastric Balloon (P140008/S026) | Boston Scientific Corporation | 2024-05-31 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S196) | Boston Scientific Corporation | 2024-05-29 |
| Innova Vascular Self-Expanding Stent System (P140028/S080) | Boston Scientific Corporation | 2024-05-20 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S030) | Boston Scientific Corporation | 2024-05-08 |
| Axonics Sacral Neuromodulation System (P180046/S083) | Boston Scientific Corporation | 2024-05-02 |