| AngioJet Rheolythic Thrombectomy Catheter (P980037/S077) | Boston Scientific Corp | 2019-12-19 |
| Rebel Platinum Chromium Coronary Stent System (Monrail and Over-The-Wire) (P130030/S064) | Boston Scientific Corp | 2019-12-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S020) | Boston Scientific Corp | 2019-12-18 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S173) | Boston Scientific Corp | 2019-12-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S021) | Boston Scientific Corp | 2019-12-13 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S034) | Boston Scientific Corp | 2019-12-12 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S171) | Boston Scientific Corp | 2019-12-12 |
| AMS 800 Artificial Urinary Sphincter (P000053/S110) | Boston Scientific Corp | 2019-12-11 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone, AMS Ambicor IPP (N970012/S172) | Boston Scientific Corp | 2019-12-11 |
| ACUITY X4 Electrode 2, 3, and (E24) (P010012/S512) | Boston Scientific Corp | 2019-12-06 |
| Precision, Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precision Montage MRI Spinal Co (P030017/S332) | Boston Scientific Corp | 2019-12-05 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S017) | Boston Scientific Corp | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S018) | Boston Scientific Corp | 2019-12-04 |
| Essentio SR, Essentio DR, Essentio EL DR, Proponent SR, Proponent DR, Proponent EL DR, Accolade SR, Accolade DR, Accola (N970003/S246) | Boston Scientific Corp | 2019-12-04 |
| Vercise, Vercise PC, and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S027) | Boston Scientific Corp | 2019-12-04 |
| AMS 800 Series Product Line/Artificial Urinary sphincter with and without InhibiZone Treatment (P000053/S109) | Boston Scientific Corp | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S019) | Boston Scientific Corp | 2019-12-04 |
| Origen CRT-D, Origen X4 CRT-D, Momentum, Momentum CRT-D, Momentum X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Dynagen CRT-D (P010012/S513) | Boston Scientific Corp | 2019-12-04 |
| Promus PREMIER/ Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S173) | Boston Scientific Corp | 2019-12-04 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S170) | Boston Scientific Corp | 2019-12-04 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S168) | Boston Scientific Corp | 2019-11-27 |
| AMS 700 Series Product Line/Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S169) | Boston Scientific Corp | 2019-11-27 |
| AMS 800 Series Product Line/ Artificial Urinary Sphincter with and without InhibiZone Treatment (P000053/S108) | Boston Scientific Corp | 2019-11-27 |
| Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D (N970003/S245) | Boston Scientific Corp | 2019-11-27 |
| PROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu (P110010/S172) | Boston Scientific Corp | 2019-11-26 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S063) | Boston Scientific Corp | 2019-11-26 |
| Rotablator (Rotablator RotaLink Plus, RotaLink Burr)/ROTAPRO Rotational Atherectomy System (ROTAPRO Plus) (P900056/S180) | Boston Scientific Corp | 2019-11-21 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S511) | Boston Scientific Corp | 2019-11-15 |
| AngioJet Rheolytic Thrombectomy System (P980037/S074) | Boston Scientific Corp | 2019-11-13 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S179) | Boston Scientific Corp | 2019-11-07 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S118) | Boston Scientific Corp | 2019-11-07 |
| Express SD Monorail Premounted Stent System (P060006/S098) | Boston Scientific Corp | 2019-11-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S062) | Boston Scientific Corp | 2019-11-07 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S171) | Boston Scientific Corp | 2019-11-07 |
| WOLVERINE Coronary Cutting Balloon (P950020/S099) | Boston Scientific Corp | 2019-11-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S050) | Boston Scientific Corp | 2019-11-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S091) | Boston Scientific Corp | 2019-11-07 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S170) | Boston Scientific Corp | 2019-11-01 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S510) | Boston Scientific Corp | 2019-10-29 |
| Non-MRI Pacemakers (N970003/S244) | Boston Scientific Corp | 2019-10-29 |
| Vercise PC and Vercise Gevia Deep Brian Stimulation (DBS) System (P150031/S021) | Boston Scientific Corp | 2019-10-20 |
| Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage and Precision Montage MRI Spinal Cord Stimulato (P030017/S328) | Boston Scientific Corp | 2019-10-20 |
| Pacemaker Devices: ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S242) | Boston Scientific Corp | 2019-10-18 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S508) | Boston Scientific Corp | 2019-10-18 |
| WATCHMAN Left Atrial Appendage Closure Device (P130013/S033) | Boston Scientific Corp | 2019-10-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S012) | Boston Scientific Corp | 2019-10-11 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C (P110010/S169) | Boston Scientific Corp | 2019-10-11 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S013) | Boston Scientific Corp | 2019-10-11 |
| Epic Vascular Self Expanding Stent System (P110035/S053) | Boston Scientific Corp | 2019-10-07 |
| Wallstent Endoprostheis TIPS with Unistep Plus (P930031/S066) | Boston Scientific Corp | 2019-10-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S016) | Boston Scientific Corp | 2019-10-07 |
| IntellaTip MiFi Open Irrigated (P150005/S048) | Boston Scientific Corp | 2019-10-07 |
| AngioJet Ultra Thrombectomy System (P980037/S076) | Boston Scientific Corp | 2019-09-30 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, and Resonate Cardiac Resynchronization Therapy Defibrillator (CRT- (P010012/S509) | Boston Scientific Corp | 2019-09-24 |
| Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage (P030017/S330) | Boston Scientific Corp | 2019-09-24 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems (P150031/S024) | Boston Scientific Corp | 2019-09-24 |
| Essentio, Proponent, Accolade, and Altrua 2 Non-MRI Pacemakers (N970003/S243) | Boston Scientific Corp | 2019-09-24 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S015) | Boston Scientific Corp | 2019-09-23 |
| AMS 800 Artificial Urinary Sphincter (AUS) with and without InhibiZone, and the AMS Ambicor Inflatable Penile Prosthesis (P000053/S107) | Boston Scientific Corp | 2019-09-20 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone (N970012/S167) | Boston Scientific Corp | 2019-09-20 |
| Autogen, Dynagen, Inogen, and Origen NG3 CRT-Ds and Resonate, Momentum, and Vigilant NG4 CRT-Ds (P010012/S506) | Boston Scientific Corp | 2019-09-18 |
| Altrua 2, Essentio, Proponent, and Accolade Non-MRI Pacemakers (N970003/S241) | Boston Scientific Corp | 2019-09-18 |
| Implantable Pulse Generator (IPG), Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, and Precisi (P030017/S329) | Boston Scientific Corp | 2019-09-13 |
| Precision Spectra and Spectra Wave Writer Spinal Cord Stimulator (SCS) Systems (P030017/S327) | Boston Scientific Corp | 2019-09-13 |
| Epic Vascular Self-Expanding Stent System (P110035/S052) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S011) | Boston Scientific Corp | 2019-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S014) | Boston Scientific Corp | 2019-09-13 |
| Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) System (P150031/S023) | Boston Scientific Corp | 2019-09-12 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S010) | Boston Scientific Corp | 2019-09-06 |
| Vercise Deep Brain Stimulation (DBS) Systems (P150031/S022) | Boston Scientific Corp | 2019-09-04 |
| AMS 700 Inflatable Penile Prosthesis, and AMS Ambicor Inflatable Penile Prosthesis (N970012/S166) | Boston Scientific Corp | 2019-08-30 |
| AMS 800 Artificial Urinary Sphincter (P000053/S106) | Boston Scientific Corp | 2019-08-30 |
| Maestro 4000 Controller Firmware (P920047/S117) | Boston Scientific Corp | 2019-08-23 |
| Blazer OI, IntellaNav OI, IntellaTip Mifi OI, and IntellaNav Mifi OI Cardiac Ablation Percutaneous Catheter (P150005/S047) | Boston Scientific Corp | 2019-08-23 |
| Maestro 4000 Controller Firmware (P980003/S090) | Boston Scientific Corp | 2019-08-23 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW) and Prom (P110010/S168) | Boston Scientific Corp | 2019-08-20 |
| Vercise Gevia DBS System and Directional Lead-only System (P150031/S011) | Boston Scientific Corp | 2019-08-19 |
| Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, and Origen Cardiac Resynchronization Therapy Defibrillators (CRT (P010012/S504) | Boston Scientific Corp | 2019-07-31 |
| REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE (P130030/S061) | Boston Scientific Corp | 2019-07-25 |
| WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (P930031/S065) | Boston Scientific Corp | 2019-07-25 |
| PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S167) | Boston Scientific Corp | 2019-07-25 |
| EPIC SELF-EXPANDING NITINOL STENT SYSTEM (P110035/S051) | Boston Scientific Corp | 2019-07-25 |
| BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM (P060006/S097) | Boston Scientific Corp | 2019-07-25 |
| FLEXATOME CUTTING BALLOON (P950020/S098) | Boston Scientific Corp | 2019-07-25 |
| ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER (P980037/S075) | Boston Scientific Corp | 2019-07-25 |
| CAROTID WALLSTENT MONORAIL ENDOPROSTHESIS (P050019/S031) | Boston Scientific Corp | 2019-07-25 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S009) | Boston Scientific Corp | 2019-07-25 |
| Momentum, Resonate, Autogen, and Dynagen (CRT-D) (P010012/S507) | Boston Scientific Corp | 2019-07-18 |
| AMS 700 Implantable Penile Prosthesis (IPP) with and without Inhibizone Treatment (N970012/S165) | Boston Scientific Corp | 2019-07-11 |
| Watchman Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S032) | Boston Scientific Corp | 2019-07-09 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE and PROPONENT Pacemaker Devices (N970003/S239) | Boston Scientific Corp | 2019-07-08 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT and PERCIVA CRT-D Res (P010012/S502) | Boston Scientific Corp | 2019-07-08 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S498) | Boston Scientific Corp | 2019-07-08 |
| Pacemaker Devices: ADVANTIO, INEGNIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, and PROPONENT (N970003/S236) | Boston Scientific Corp | 2019-07-08 |
| Precision Spectra, Precision Novi, Precision Montage, and Precision Montage MRI, Spectra WaveWriter Spinal Cord Stimulat (P030017/S326) | Boston Scientific Corp | 2019-07-02 |
| NG3 and NG4 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) (P010012/S505) | Boston Scientific Corp | 2019-06-21 |
| Accolade Pacemakers (N970003/S240) | Boston Scientific Corp | 2019-06-21 |
| Express SD Premounted Stent System (ESD) (P060006/S096) | Boston Scientific Corp | 2019-06-18 |
| REBEL Plantinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S060) | Boston Scientific Corp | 2019-06-18 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S008) | Boston Scientific Corp | 2019-06-18 |