| ALTRUA 2 (Models S701, S702, S722) ESSENTIO (Models L100, L101, L121) PROPONENT (Models L200, L201, L221) ACCOLADE ( (N970003/S304) | Boston Scientific Corp | 2025-12-19 |
| WaveWriter Alpha Spinal Cord Stimulator (SCS) Mixed Systems, M8 Adaptor (P030017/S374) | Boston Scientific Corp | 2025-12-18 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S082) | Boston Scientific Corp | 2025-12-18 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S090) | Boston Scientific Corp | 2025-12-17 |
| ALTRUA 2 (Model S722); ESSENTIO (Model L121); PROPONENT (Model L221); ACCOLADE (Model L321) (N970003/S305) | Boston Scientific Corp | 2025-12-17 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S390) | Boston Scientific Corp | 2025-12-17 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S079) | Boston Scientific Corp | 2025-12-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (P130013/S078) | Boston Scientific Corp | 2025-12-15 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage ( (P130013/S080) | Boston Scientific Corp | 2025-12-12 |
| Vercise Genus Deep Brain Stimulation (DBS) Systems (P150031/S089) | Boston Scientific Corp | 2025-12-10 |
| WaveWriter Alpha Prime Spinal Cord Stimulation (SCS) Systems (P030017/S389) | Boston Scientific Corp | 2025-12-10 |
| Intellagen Irrigation Tubing Set (P150005/S090) | Boston Scientific Corp | 2025-12-05 |
| WOLVERINE Coronary Cutting Balloon (P950020/S147) | Boston Scientific Corp | 2025-12-01 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Left Atrial Appendage Closure D (P130013/S081) | Boston Scientific Corp | 2025-11-06 |
| ROTAPRO Rotational Atherectomy System (P900056/S222) | Boston Scientific Corp | 2025-10-27 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S067) | Boston Scientific Corp | 2025-10-24 |
| ACUITY X4 Leads (P010012/S593) | Boston Scientific Corp | 2025-10-24 |
| G124 MOMENTUM CRT-D,G125 MOMENTUM CRT-D,G126 MOMENTUM CRT-D,G128 MOMENTUM,G138 MOMENTUM X4 CRT-D,G140 INOGEN CRT-D, (P010012/S599) | Boston Scientific Corp | 2025-10-22 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN C (P010012/S598) | Boston Scientific Corp | 2025-10-22 |
| L100 ESSENTIO SR,L101 ESSENTIO DR,L121 ESSENTIO EL DR,L200 PROPONENT SR,L201 PROPONENT DR,L221 PROPONENT EL DR,L30 (N970003/S303) | Boston Scientific Corp | 2025-10-22 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010) (P920047/S138) | Boston Scientific Corp | 2025-10-17 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (M004RA65010); Rhythmia HDx Ablation Connection Box (Maestro) (P150005/S091) | Boston Scientific Corp | 2025-10-17 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S210) | Boston Scientific Corp | 2025-10-02 |
| Cardiac Resynchronization Therapy Defibrillators INOGEN (Models G140, G141, G146, G148); DYNAGEN (Models G150, G151, G15 (P010012/S595) | Boston Scientific Corp | 2025-09-22 |
| Accolade Non-MRI Pacemakers ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models (N970003/S302) | Boston Scientific Corp | 2025-09-22 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S087) | Boston Scientific Corp | 2025-09-19 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S043) | Boston Scientific Corp | 2025-09-19 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S386) | Boston Scientific Corp | 2025-09-19 |
| ACC SUP SUTURE SLEEVE; ACC SUP FLUSHING TOOL; ACC WRENCH TORQUE-BI; ACC SUP LD CAP LV1 (P010012/S597) | Boston Scientific Corp | 2025-09-16 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S596) | Boston Scientific Corp | 2025-09-16 |
| WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY (P130013/S077) | Boston Scientific Corp | 2025-09-04 |
| ACUITY X4 Straight, Models 4671 and 4672; ACUITY X4 Spiral S, Models 4674 and 4675; ACUITY X4 Spiral L, Models 4677 and (P010012/S591) | Boston Scientific Corp | 2025-09-03 |
| Opal HDx Ablation Connection Box (Maestro); Opal HDx Ablation Connection Box - IntellaNav StablePoint; Opal HDx Ablation (P150005/S088) | Boston Scientific Corp | 2025-09-02 |
| ROTABLATOR Rotational Atherectomy System (P900056/S221) | Boston Scientific Corp | 2025-08-14 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S089) | Boston Scientific Corp | 2025-08-14 |
| Blazer II Cardiac Ablation System and Cable (P920047/S137) | Boston Scientific Corp | 2025-08-14 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S066) | Boston Scientific Corp | 2025-08-08 |
| Epic Vascular Self-Expanding Stent System (P110035/S074) | Boston Scientific Corp | 2025-08-08 |
| AngioJet Thrombectomy System (P980037/S095) | Boston Scientific Corp | 2025-08-01 |
| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S074) | Boston Scientific Corp | 2025-07-16 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S140) | Boston Scientific Corp | 2025-07-14 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (N970012/S209) | Boston Scientific Corp | 2025-07-14 |
| ALTRUA 2 (Models S701, S702, S722); ESSENTIO (Models L100, L101, L121); PROPONENT (Models L200, L201, L221); ACCOLADE (N970003/S300) | Boston Scientific Corp | 2025-07-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S208) | Boston Scientific Corp | 2025-07-01 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S086) | Boston Scientific Corp | 2025-06-25 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S384) | Boston Scientific Corp | 2025-06-25 |
| NAV 2 Quadpole LV Long Spiral; NAV 2 Quadpole LV Straight; NAV 2 Quadpole LV Short Spiral (P010012/S590) | Boston Scientific Corp | 2025-06-04 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without lnhibiZone (P000053/S137) | Boston Scientific Corp | 2025-06-03 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S085) | Boston Scientific Corp | 2025-05-29 |
| ROTAPRO Rotational Atherectomy System (P900056/S220) | Boston Scientific Corp | 2025-05-28 |
| AMS 700 Inflatable Penile Prosthesis without InhibiZone (N970012/S207) | Boston Scientific Corp | 2025-05-28 |
| AMS 800 Artificial Urinary Sphincter (AUS) (P000053/S139) | Boston Scientific Corp | 2025-05-28 |
| ROTAPRO Rotational Atherectomy System (P900056/S219) | Boston Scientific Corp | 2025-05-20 |
| Vercise Genus, Vercise Gevia, Vercise PC, Vercise DBS Systems (P150031/S083) | Boston Scientific Corp | 2025-05-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System; WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S075) | Boston Scientific Corp | 2025-05-05 |
| AngioJet Thrombectomy System - AutoElite Console (P980037/S094) | Boston Scientific Corp | 2025-05-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S071) | Boston Scientific Corp | 2025-04-25 |
| Essentio SR; Essentio DR; Essentio EL DR; Proponent SR; Proponent DR; Proponent EL DR; Accolade SR; Accolade DR; Accolad (N970003/S299) | Boston Scientific Corp | 2025-04-11 |
| Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D (P010012/S589) | Boston Scientific Corp | 2025-04-11 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (P920047/S136) | Boston Scientific Corp | 2025-03-31 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro);RHYTHMIA HDx (P150005/S087) | Boston Scientific Corp | 2025-03-31 |
| IntellaNav ST Ablation Catheter (P920047/S135) | Boston Scientific Corp | 2025-03-20 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S206) | Boston Scientific Corp | 2025-03-18 |
| WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System (P030017/S381) | Boston Scientific Corp | 2025-03-17 |
| Deep Brain Stimulation (DBS) (P150031/S082) | Boston Scientific Corp | 2025-03-17 |
| Spinal Cord Stimulation (SCS) (P030017/S382) | Boston Scientific Corp | 2025-03-17 |
| WOLVERINE Coronary Cutting Balloon (P950020/S146) | Boston Scientific Corp | 2025-02-05 |
| Vercise DBS Controller (P150031/S076) | Boston Scientific Corp | 2025-02-05 |
| AMS 800 Artificial Urinary Sphincter, AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S136) | Boston Scientific Corp | 2025-01-23 |
| Rotawire Guidewire, ROTAWIRE Drive Guidewire (P900056/S218) | Boston Scientific Corp | 2025-01-17 |
| PROMUS Element PLUS, PREMIER, ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S213) | Boston Scientific Corp | 2025-01-14 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S065) | Boston Scientific Corp | 2025-01-14 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S380) | Boston Scientific Corp | 2025-01-08 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S081) | Boston Scientific Corp | 2025-01-08 |
| Vercise Genus Deep Brain Stimulation System (P150031/S080) | Boston Scientific Corp | 2024-12-23 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S298) | Boston Scientific Corp | 2024-12-18 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S379) | Boston Scientific Corp | 2024-12-18 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S079) | Boston Scientific Corp | 2024-12-18 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S064) | Boston Scientific Corp | 2024-12-17 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S205) | Boston Scientific Corp | 2024-12-17 |
| Wolverine Coronary Cutting Balloon (Monorail) (P950020/S144) | Boston Scientific Corp | 2024-12-10 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S073) | Boston Scientific Corp | 2024-11-26 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S063) | Boston Scientific Corp | 2024-11-26 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL DR, L30 (N970003/S297) | Boston Scientific Corp | 2024-11-25 |
| G124 MOMENTUM CRT-D, G125 MOMENTUM CRT-D, G126 MOMENTUM CRT-D, G128 MOMENTUM, G138 MOMENTUM X4 CRT-D, G140 INOGEN CRT-D, (P010012/S588) | Boston Scientific Corp | 2024-11-25 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S145) | Boston Scientific Corp | 2024-11-22 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S042) | Boston Scientific Corp | 2024-11-19 |
| Blazer Open Irrigated Ablation Catheter, IntellaNav Open Irrigated Ablation Catheter, IntellaNav MiFi Open Irrigated Abl (P150005/S086) | Boston Scientific Corp | 2024-11-14 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S065) | Boston Scientific Corp | 2024-11-13 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S378) | Boston Scientific Corp | 2024-11-07 |
| NAV 2 Quadpole LV Straight 86CM 4671, NAV 2 Quadpole LV Straight 95CM 4672, NAV 2 Quadpole LV Short Spiral 86CM 4674, N (P010012/S587) | Boston Scientific Corp | 2024-11-07 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S078) | Boston Scientific Corp | 2024-11-07 |
| ACCOLADE (N970003/S295) | Boston Scientific Corp | 2024-11-01 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S072) | Boston Scientific Corp | 2024-11-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S062) | Boston Scientific Corp | 2024-10-28 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S296) | Boston Scientific Corp | 2024-10-23 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S586) | Boston Scientific Corp | 2024-10-23 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S061) | Boston Scientific Corp | 2024-10-18 |
| AMS 800 Artificial Urinary Sphincter (with and without InhibiZone) (P000053/S130) | Boston Scientific Corp | 2024-10-08 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Closure D (P130013/S070) | Boston Scientific Corp | 2024-09-23 |