| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S289) | Boston Scientific Corp | 2023-10-18 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S576) | Boston Scientific Corp | 2023-10-18 |
| Vercise Genus DBS Systems, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S060) | Boston Scientific Corp | 2023-10-10 |
| PG PROPONENT SR SL US, PG PROPONENT DR SL US, PG PROPONENT DR EL US, PG ACCOLADE SR SL US,PG ACCOLADE DR SL US, PG ACCOL (N970003/S288) | Boston Scientific Corp | 2023-10-06 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWriter A (P030017/S357) | Boston Scientific Corp | 2023-10-05 |
| ROTAPRO and Rotalink Rotational Atherectomy System (P900056/S211) | Boston Scientific Corp | 2023-09-28 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, WaveWri (P030017/S366) | Boston Scientific Corp | 2023-09-27 |
| Vercise PC, Vercise Gevia, Vercise Genus Deep Brain Stimlation (DBS) Systems (P150031/S061) | Boston Scientific Corp | 2023-09-27 |
| Eluvia Drug Eluting Stent System (P180011/S056) | Boston Scientific Corp | 2023-09-21 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone, AMS Ambicor Inflatable Pe (N970012/S196) | Boston Scientific Corp | 2023-09-20 |
| Epic Self Expanding Stent System (P110035/S070) | Boston Scientific Corp | 2023-09-18 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S199) | Boston Scientific Corp | 2023-09-15 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S057) | Boston Scientific Corp | 2023-09-06 |
| Vercise S8 Adapter (P150031/S055) | Boston Scientific Corp | 2023-09-06 |
| Express SD Renal (P060006/S108) | Boston Scientific Corp | 2023-08-31 |
| Rotablator, ROTAPRO Rotational Atherectomy System (P900056/S210) | Boston Scientific Corp | 2023-08-29 |
| Rotaglide Lubricant (P900056/S201) | Boston Scientific Corp | 2023-08-17 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S039) | Boston Scientific Corp | 2023-08-10 |
| AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set (P980037/S090) | Boston Scientific Corp | 2023-08-08 |
| WALLSTENT Endoprosthesis (P930031/S073) | Boston Scientific Corp | 2023-08-04 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S140) | Boston Scientific Corp | 2023-08-03 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S076) | Boston Scientific Corp | 2023-07-27 |
| WOLVERINE Coronary Cutting Balloon (P950020/S139) | Boston Scientific Corp | 2023-07-27 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S107) | Boston Scientific Corp | 2023-07-27 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S078) | Boston Scientific Corp | 2023-07-27 |
| Chilli Cooled Rf Ablation System (P980003/S096) | Boston Scientific Corp | 2023-07-27 |
| Rotablator Rotational Atherectomy System (P900056/S209) | Boston Scientific Corp | 2023-07-27 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S211) | Boston Scientific Corp | 2023-07-27 |
| Blazer II Cardiac Ablation System and Cable (P920047/S132) | Boston Scientific Corp | 2023-07-27 |
| - ESSENTIO SR, ESSENTIO DR, SSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR (N970003/S287) | Boston Scientific Corp | 2023-07-21 |
| ACUITY Spiral, Accessory, Slit Suture Sleeve, ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L, Slit Sutu (P010012/S575) | Boston Scientific Corp | 2023-07-21 |
| MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S574) | Boston Scientific Corp | 2023-07-20 |
| ROTAPRO Rotational Atherectomy System (P900056/S208) | Boston Scientific Corp | 2023-07-17 |
| IntellaNav MiFi Open-Irrigated (OI) Ablation Catheter (P150005/S076) | Boston Scientific Corp | 2023-07-17 |
| Vercise Genus DBS System, Vercise Gevia DBS System, Vercise PC DBS System (P150031/S056) | Boston Scientific Corp | 2023-07-10 |
| Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S573) | Boston Scientific Corp | 2023-07-07 |
| ACUITY Spiral, ACUITY X4 Straight, ACUITY X4 Spiral (P010012/S572) | Boston Scientific Corp | 2023-07-06 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S059) | Boston Scientific Corp | 2023-06-30 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S364) | Boston Scientific Corp | 2023-06-30 |
| AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S198) | Boston Scientific Corp | 2023-06-28 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S131) | Boston Scientific Corp | 2023-06-28 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S038) | Boston Scientific Corp | 2023-06-14 |
| WALLSTENT TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S072) | Boston Scientific Corp | 2023-06-14 |
| Precision Passing Elevator (P030017/S351) | Boston Scientific Corp | 2023-06-06 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S360) | Boston Scientific Corp | 2023-05-17 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S362) | Boston Scientific Corp | 2023-05-15 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S058) | Boston Scientific Corp | 2023-05-15 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S057) | Boston Scientific Corp | 2023-05-12 |
| Precision Spinal Cord Stimulator (SCS Systems) (P030017/S361) | Boston Scientific Corp | 2023-05-12 |
| NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), NG4 CRT-Ds (P010012/S568) | Boston Scientific Corp | 2023-05-11 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S052) | Boston Scientific Corp | 2023-05-11 |
| Accolade Pacemakers (N970003/S284) | Boston Scientific Corp | 2023-05-11 |
| Rotablator and ROTAPRO Rotational Atherectomy Systems (P900056/S207) | Boston Scientific Corp | 2023-05-10 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S286) | Boston Scientific Corp | 2023-05-08 |
| Wolverine Coronary Cutting Balloon (P950020/S138) | Boston Scientific Corp | 2023-05-05 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (N970003/S285) | Boston Scientific Corp | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P010012/S569) | Boston Scientific Corp | 2023-05-01 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S206) | Boston Scientific Corp | 2023-04-27 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S075) | Boston Scientific Corp | 2023-04-27 |
| Blazer II Cardiac Ablation System (P920047/S130) | Boston Scientific Corp | 2023-04-27 |
| Chilli II Cooled RF Ablation System (P980003/S095) | Boston Scientific Corp | 2023-04-27 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S137) | Boston Scientific Corp | 2023-04-26 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, INSIGNIA, ALTRUA 2 (N970003/S283) | Boston Scientific Corp | 2023-04-21 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S567) | Boston Scientific Corp | 2023-04-21 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S205) | Boston Scientific Corp | 2023-04-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S052) | Boston Scientific Corp | 2023-04-10 |
| Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System MR, Promus Premier Everolimus-Eluting Platinum C (P110010/S210) | Boston Scientific Corp | 2023-04-10 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S058) | Boston Scientific Corp | 2023-03-29 |
| Epic Vascular Self-Expanding Stent System (P110035/S069) | Boston Scientific Corp | 2023-03-21 |
| Eluvia Drug Eluting Vascular Stent System (P180011/S054) | Boston Scientific Corp | 2023-03-21 |
| PROMUS ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S208) | Boston Scientific Corp | 2023-03-15 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S135) | Boston Scientific Corp | 2023-03-10 |
| Promus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S209) | Boston Scientific Corp | 2023-03-10 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S037) | Boston Scientific Corp | 2023-03-10 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S136) | Boston Scientific Corp | 2023-03-09 |
| Express SD Renal Monorail Premounted Stent System (P060006/S106) | Boston Scientific Corp | 2023-03-08 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro (P110010/S207) | Boston Scientific Corp | 2023-03-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S075) | Boston Scientific Corp | 2023-03-02 |
| Wolverine Coronary Cutting Balloon (P950020/S133) | Boston Scientific Corp | 2023-03-02 |
| Express SD Renal Monorail Premounted Stent System (P060006/S105) | Boston Scientific Corp | 2023-03-02 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone (P000053/S129) | Boston Scientific Corp | 2023-02-23 |
| Vercise Genus DBS System (P150031/S052) | Boston Scientific Corp | 2023-02-23 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S053) | Boston Scientific Corp | 2023-02-16 |
| AMS 700 Inflatable Penile Prosthesis, AMS 700 Inflatable Penile Prosthesis with InhibiZone (N970012/S195) | Boston Scientific Corp | 2023-02-10 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S204) | Boston Scientific Corp | 2023-02-02 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S035) | Boston Scientific Corp | 2023-02-01 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S053) | Boston Scientific Corp | 2023-01-20 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S056) | Boston Scientific Corp | 2023-01-20 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S134) | Boston Scientific Corp | 2023-01-18 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S054) | Boston Scientific Corp | 2023-01-06 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S356) | Boston Scientific Corp | 2023-01-06 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, Spectra WaveWriter, and WaveWriter Alpha Sp (P030017/S359) | Boston Scientific Corp | 2023-01-04 |
| MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S566) | Boston Scientific Corp | 2022-12-20 |
| ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR (N970003/S282) | Boston Scientific Corp | 2022-12-20 |
| CRT-D Resynchronization Devices (P010012/S559) | Boston Scientific Corp | 2022-12-20 |
| Pacemaker Devices (N970003/S277) | Boston Scientific Corp | 2022-12-20 |
| Wave Writer Alpha Spinal Cord Stimulator (SCS) System, Spectra Wave Writer Spinal Cord Stimulator (SCS) System, Precis (P030017/S353) | Boston Scientific Corp | 2022-12-19 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S355) | Boston Scientific Corp | 2022-12-17 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S053) | Boston Scientific Corp | 2022-12-17 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S281) | Boston Scientific Corp | 2022-12-14 |