| Vercise Deep Brain Stimulation (DBS) System (P150031/S031) | Boston Scientific Corp | 2020-06-29 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S067) | Boston Scientific Corp | 2020-06-25 |
| Rotablator Rotational Atherectomy System, ROTAPRO Rotational Atherectomy System (P900056/S185) | Boston Scientific Corp | 2020-06-16 |
| AMS 800 Series Product Line/Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S113) | Boston Scientific Corp | 2020-06-16 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S178) | Boston Scientific Corp | 2020-06-16 |
| (Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S251) | Boston Scientific Corp | 2020-06-15 |
| (CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU (P010012/S518) | Boston Scientific Corp | 2020-06-15 |
| WOLVERINE Coronary Cutting Balloon (P950020/S108) | Boston Scientific Corp | 2020-06-12 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S032) | Boston Scientific Corp | 2020-06-12 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S179) | Boston Scientific Corp | 2020-06-09 |
| Blazer Prime XP cardiac ablation catheters (P920047/S123) | Boston Scientific Corp | 2020-06-04 |
| IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters (P150005/S056) | Boston Scientific Corp | 2020-06-04 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S054) | Boston Scientific Corp | 2020-05-29 |
| IntellaNav OI, and IntellaNav MiFi OI (P150005/S055) | Boston Scientific Corp | 2020-05-28 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031/S035) | Boston Scientific Corp | 2020-05-27 |
| Precision Spinal Cord Stimulator(SCS) Systems (P030017/S339) | Boston Scientific Corp | 2020-05-27 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S031) | Boston Scientific Corp | 2020-05-21 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S177) | Boston Scientific Corp | 2020-05-20 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S112) | Boston Scientific Corp | 2020-05-20 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S092) | Boston Scientific Corp | 2020-05-19 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S184) | Boston Scientific Corp | 2020-05-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S053) | Boston Scientific Corp | 2020-05-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S122) | Boston Scientific Corp | 2020-05-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S028) | Boston Scientific Corp | 2020-05-19 |
| Express SD Monorail Premounted Stent System (P060006/S100) | Boston Scientific Corp | 2020-05-19 |
| Epic Vascular Self-Expanding Stent System (P110035/S057) | Boston Scientific Corp | 2020-05-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S106) | Boston Scientific Corp | 2020-05-19 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S079) | Boston Scientific Corp | 2020-05-19 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S067) | Boston Scientific Corp | 2020-05-19 |
| PROMUS Element PLUS/PREMIER/ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S176) | Boston Scientific Corp | 2020-05-19 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S033) | Boston Scientific Corp | 2020-05-15 |
| Precision Spinal Cord Stimulator (SCS) Systems (P030017/S337) | Boston Scientific Corp | 2020-05-15 |
| Precision Spinal Cord Stimulator (SCS) Systems, (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montag (P030017/S336) | Boston Scientific Corp | 2020-05-13 |
| Deep Brain Stimulation (DBS) Systems (Vercise, Vercise PC, and Vercise Gevia) (P150031/S032) | Boston Scientific Corp | 2020-05-13 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S178) | Boston Scientific Corp | 2020-05-06 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S078) | Boston Scientific Corp | 2020-05-05 |
| Epic Vascular Self-Expanding Stent System (P110035/S056) | Boston Scientific Corp | 2020-05-05 |
| Vercise Deep Brain Stimulation (DBS) System, Vercise PC Deep Brain Stimulation (DBS) System, and Vercise Gevia Deep Brai (P150031/S030) | Boston Scientific Corp | 2020-04-24 |
| Precision Spinal Cord Stimulator (SCS) System, Precision Spectra Spinal Cord Stimulator (SCS) System, Precision Novi⢠(P030017/S335) | Boston Scientific Corp | 2020-04-24 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S029) | Boston Scientific Corp | 2020-04-22 |
| Epic Vascular Self-Expanding Stent System (P110035/S059) | Boston Scientific Corp | 2020-04-20 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S030) | Boston Scientific Corp | 2020-04-20 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI, and Spectra WaveWriter Spinal Co (P030017/S334) | Boston Scientific Corp | 2020-04-17 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S049) | Boston Scientific Corp | 2020-04-17 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S025) | Boston Scientific Corp | 2020-04-16 |
| Epic Vascular Self-Expanding Stent System (P110035/S058) | Boston Scientific Corp | 2020-04-13 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S080) | Boston Scientific Corp | 2020-04-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S037) | Boston Scientific Corp | 2020-04-11 |
| Vercise PC and Vercise Gevia DBS Systems (P150031/S026) | Boston Scientific Corp | 2020-04-10 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S176) | Boston Scientific Corp | 2020-04-09 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S519) | Boston Scientific Corp | 2020-04-07 |
| Promus PREMIER and Promus ELITE (P110010/S177) | Boston Scientific Corp | 2020-04-03 |
| WOLVERINE Coronary Cutting Balloon (P950020/S107) | Boston Scientific Corp | 2020-04-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S068) | Boston Scientific Corp | 2020-04-02 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S514) | Boston Scientific Corp | 2020-04-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S024) | Boston Scientific Corp | 2020-04-01 |
| Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported (N970003/S247) | Boston Scientific Corp | 2020-04-01 |
| WOLVERINE Coronary Cutting Balloon (P950020/S105) | Boston Scientific Corp | 2020-03-25 |
| WOLVERINE Coronary Cutting Balloon (P950020/S097) | Boston Scientific Corp | 2020-03-17 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S250) | Boston Scientific Corp | 2020-03-17 |
| Precision, Precision Novi, Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S333) | Boston Scientific Corp | 2020-03-17 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT- (P010012/S517) | Boston Scientific Corp | 2020-03-17 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S029) | Boston Scientific Corp | 2020-03-17 |
| AMS 800 Series Product Line/Artifical Urinary Sphincter with and without InhibiZone Treatment (P000053/S111) | Boston Scientific Corp | 2020-03-06 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S175) | Boston Scientific Corp | 2020-03-06 |
| PG ADVANTIO DR, PG INGENIO DR, PG VITALIO DR, PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOL (N970003/S249) | Boston Scientific Corp | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S103) | Boston Scientific Corp | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S104) | Boston Scientific Corp | 2020-03-05 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S516) | Boston Scientific Corp | 2020-03-05 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S066) | Boston Scientific Corp | 2020-03-02 |
| PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS Premier Everolimus-Eluting Platinum Chro (P110010/S175) | Boston Scientific Corp | 2020-03-02 |
| Express SD Premounted Renal Stent System (P060006/S099) | Boston Scientific Corp | 2020-03-02 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System (P130013/S036) | Boston Scientific Corp | 2020-02-27 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S027) | Boston Scientific Corp | 2020-02-27 |
| WOLVERINE Coronary Cutting Balloon (Over-The-Wire and Monorail) (P950020/S102) | Boston Scientific Corp | 2020-02-24 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S174) | Boston Scientific Corp | 2020-02-21 |
| Epic Vascular Self-Expanding Stent System (P110035/S055) | Boston Scientific Corp | 2020-02-20 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S026) | Boston Scientific Corp | 2020-02-20 |
| WOLVERINE Coronary Cutting Balloon (P950020/S101) | Boston Scientific Corp | 2020-02-20 |
| IntellaNav ST Temperature Ablation Catheter (P920047/S121) | Boston Scientific Corp | 2020-02-19 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Open-Irrigated Ablation Catheters (P150005/S052) | Boston Scientific Corp | 2020-02-19 |
| AMS 800 Artificial Urinary Sphincter with InhibiZone (P000053/S104) | Boston Scientific Corp | 2020-02-13 |
| AMS 700 Inflatable Penile Prosthesis (N970012/S163) | Boston Scientific Corp | 2020-02-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S023) | Boston Scientific Corp | 2020-02-12 |
| Blazer Prime HTD (P920047/S120) | Boston Scientific Corp | 2020-02-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S022) | Boston Scientific Corp | 2020-02-06 |
| Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch (P110010/S174) | Boston Scientific Corp | 2020-02-06 |
| Rotapro Rotational Atherectomy System (P900056/S181) | Boston Scientific Corp | 2020-01-30 |
| PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL (N970003/S248) | Boston Scientific Corp | 2020-01-28 |
| ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1 (P010012/S515) | Boston Scientific Corp | 2020-01-28 |
| IntellaNav OI and IntellaNav MiFi OI (P150005/S051) | Boston Scientific Corp | 2020-01-27 |
| IntellaNav ST (P920047/S119) | Boston Scientific Corp | 2020-01-27 |
| Percision, Precision Spectra, Spectra WaveWriter; Precision Novi, Percision Montage and Percision Montage MRI Spinal Co (P030017/S331) | Boston Scientific Corp | 2020-01-24 |
| REBEL Platinum Chromium Coronary Stent System Monorail (P130030/S065) | Boston Scientific Corp | 2020-01-09 |
| WOLVERINE Coronary Cutting Balloon Monorail (P950020/S100) | Boston Scientific Corp | 2020-01-09 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S164) | Boston Scientific Corp | 2020-01-03 |
| PROMUS Element Plus, PREMIER and ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S163) | Boston Scientific Corp | 2020-01-03 |
| AMS 800 Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S105) | Boston Scientific Corp | 2019-12-30 |
| AMS 700 Implantable numbera Penile Prosthesis with and without Inhibizone Treatment (N970012/S164) | Boston Scientific Corp | 2019-12-30 |
| Epic Vascular Self-Expanding Stent System (P110035/S054) | Boston Scientific Corp | 2019-12-19 |