| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S311) | Boston Scientific Corp | 2018-03-12 |
| Precision Montage MRI Spinal Cord Stimulator System (P030017/S308) | Boston Scientific Corp | 2018-03-12 |
| Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN, (P010012/S481) | Boston Scientific Corp | 2018-03-12 |
| Accolade Non-MRI Pacemakers: ADVANTIO, INGENIO, VITALIO, ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S226) | Boston Scientific Corp | 2018-03-12 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Premier Everolimus-Eluting Pla (P110010/S153) | Boston Scientific Corp | 2018-02-23 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S029) | Boston Scientific Corp | 2018-02-22 |
| NG3 Cardiac Resynchronization Therapy Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 Cardiac Resynchronization (P010012/S479) | Boston Scientific Corp | 2018-02-21 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S017) | Boston Scientific Corp | 2018-02-21 |
| PROMUS Element Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent (P110010/S152) | Boston Scientific Corp | 2018-02-16 |
| Rotablator Rotational Atherectomy System (P900056/S169) | Boston Scientific Corp | 2018-02-16 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S048) | Boston Scientific Corp | 2018-02-16 |
| Express SD Monorail Premounted Stent System (P060006/S090) | Boston Scientific Corp | 2018-02-16 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S034) | Boston Scientific Corp | 2018-02-16 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S107) | Boston Scientific Corp | 2018-02-16 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S084) | Boston Scientific Corp | 2018-02-16 |
| Urinary Control System (P000053/S087) | Boston Scientific Corp | 2018-02-13 |
| Inflatable Penile Prosthesis (N970012/S144) | Boston Scientific Corp | 2018-02-13 |
| BSC Intella Nav MIFI OI Ablation Cathetrs (P150005/S033) | Boston Scientific Corp | 2018-02-09 |
| IntellaNav St Cardiac Ablation Catheter (P920047/S104) | Boston Scientific Corp | 2018-02-09 |
| DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOMENTUM X4; VIGILIANT X4; RESONATE X4/HF; PUNCTUA; ENERGEN; INCEPTA CRT-D (P010012/S478) | Boston Scientific Corp | 2018-02-08 |
| Flextome Coronary Cutting Balloon (P950020/S088) | Boston Scientific Corp | 2018-02-08 |
| AngioJet Ultra Thrombectomy System Console (P980037/S068) | Boston Scientific Corp | 2018-02-08 |
| ACCOLADE; PROPONENT; ESSENTIO; ALTRUA 2 PACEMAKER (N970003/S225) | Boston Scientific Corp | 2018-02-08 |
| AngioJet Ultra Console (P980037/S069) | Boston Scientific Corp | 2018-02-08 |
| Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update (P030017/S307) | Boston Scientific Corp | 2018-02-05 |
| NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Origen) / NG4 Family of CRT-Ds (Resonate, Vigilant) (P010012/S473) | Boston Scientific Corp | 2018-02-02 |
| Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade) (N970003/S223) | Boston Scientific Corp | 2018-02-02 |
| AMS 800 Urinary Control System with and without InhibiZone Treatment (P000053/S086) | Boston Scientific Corp | 2018-02-01 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S088) | Boston Scientific Corp | 2018-02-01 |
| Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S306) | Boston Scientific Corp | 2018-01-31 |
| AMS 700 Implantable/Inflatable Penile Prosthesis with and without InhibiZone Treatment (N970012/S143) | Boston Scientific Corp | 2018-01-30 |
| Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate, Punctua, Energen, Incepta CRT-D (P010012/S475) | Boston Scientific Corp | 2018-01-19 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S310) | Boston Scientific Corp | 2018-01-19 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S300) | Boston Scientific Corp | 2018-01-19 |
| Precision WaveWriter Spinal Cord Stimulator (SCS) System / WaveWriter IPG Test Equipment System (P030017/S309) | Boston Scientific Corp | 2018-01-17 |
| Cardiac Resynchronization Therapy Defibrillator Momentum, Vigilant, Resonate (P010012/S476) | Boston Scientific Corp | 2018-01-15 |
| DYNAGEN CRT-D AND X4 CRT-D; INOGEN CRT-D AND X4 CRT-D; ORIGEN CRT-D AND X4 CRT-D; AUTOGEN CRT-D AND X4 CRT-D; INCEPTA, E (P010012/S474) | Boston Scientific Corp | 2018-01-10 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S217) | Boston Scientific Corp | 2018-01-07 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S467) | Boston Scientific Corp | 2018-01-07 |
| Spectra WaveWriter Spinal Cord Stimulator System (P030017/S302) | Boston Scientific Corp | 2017-12-22 |
| Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S014) | Boston Scientific Corp | 2017-12-21 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S297) | Boston Scientific Corp | 2017-12-21 |
| Autogen, Cognis, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Punctua, Resonate, Vigiliant, CRT-Ds (P010012/S472) | Boston Scientific Corp | 2017-12-19 |
| Accolade, Advantio, Altrua, Altrua 2, Essentio, Formio, Ingenio, Insignia, Proponent, Vitalio Pacemakers (N970003/S222) | Boston Scientific Corp | 2017-12-19 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S140) | Boston Scientific Corp | 2017-12-18 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S047) | Boston Scientific Corp | 2017-12-15 |
| AMS 700 Implantable Penile Prosthesis (with and without InhibiZone Treatment) / AMS Ambicor Implantable Penile Prosthesi (N970012/S141) | Boston Scientific Corp | 2017-12-15 |
| AMS 800 Urinary Control System (with and without Inhibizone Treatment) (P000053/S084) | Boston Scientific Corp | 2017-12-15 |
| Express SD Renal Monorail Premounted Stent System (P060006/S089) | Boston Scientific Corp | 2017-12-15 |
| Epic Vascular Self-Expanding Stent System (P110035/S044) | Boston Scientific Corp | 2017-12-14 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigilant (P010012/S465) | Boston Scientific Corp | 2017-12-13 |
| Infuse Bone Graft (P050053/S040) | Boston Scientific Corp | 2017-12-13 |
| Advantio, Ingenio, Vitalio, formio, Essentio, Accolade, Proponent, Insignia, Altrua 2 (N970003/S213) | Boston Scientific Corp | 2017-12-13 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S085) | Boston Scientific Corp | 2017-12-12 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S150) | Boston Scientific Corp | 2017-12-12 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S142) | Boston Scientific Corp | 2017-12-12 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE (N970003/S219) | Boston Scientific Corp | 2017-12-11 |
| NG3 Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Devices: AUTOGEN, DYNAGEN, INOGEN and ORIGEN; NG4 CRT-D Devi (P010012/S469) | Boston Scientific Corp | 2017-12-11 |
| VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (P150031) | Boston Scientific Corp | 2017-12-08 |
| ALTRUA 2, ESSONTIO, PROPONENT, ACCOLADE, ADVANTIO, INGENIO, VITALIO, Non-MRI Pacemakers (N970003/S220) | Boston Scientific Corp | 2017-12-06 |
| ORIGEN / INOGEN / DYNAGEN / AUTOGEN / MOMENTUM / VIGILANT / RESONATE / Implantable Cardiac Resynchronization Therapy Def (P010012/S471) | Boston Scientific Corp | 2017-12-06 |
| ALTRUA 2 / ESSENTIO / PROPONENT / ACCOLADE / Accolade Non-MRI Pacemakers (N970003/S221) | Boston Scientific Corp | 2017-12-06 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE, PERCIVA, PUNCTUA, ENERGEN, INCEPTA , Cardiac Resynchroni (P010012/S470) | Boston Scientific Corp | 2017-12-06 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S016) | Boston Scientific Corp | 2017-12-05 |
| Rotablator Rotational Atherectomy System (P900056/S168) | Boston Scientific Corp | 2017-12-01 |
| Express SD Monorail Premounted Stent System (P060006/S088) | Boston Scientific Corp | 2017-12-01 |
| Accolade, Altrua 2, Essentio, Proponent (Accolade), Advantio, Ingenio, Vitalio, Formio (Ingenio) (N970003/S218) | Boston Scientific Corp | 2017-12-01 |
| PROMUS Elemen Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent S (P110010/S149) | Boston Scientific Corp | 2017-12-01 |
| Autogen, Dynagen, Inogen, Origen (NG3 CRT-Ds), Momentum, Resonate, Vigilant (NG4 CRT-Ds) (P010012/S468) | Boston Scientific Corp | 2017-12-01 |
| Spectra WaveWriter SCS System (P030017/S305) | Boston Scientific Corp | 2017-12-01 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S046) | Boston Scientific Corp | 2017-12-01 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S032) | Boston Scientific Corp | 2017-12-01 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S083) | Boston Scientific Corp | 2017-12-01 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S106) | Boston Scientific Corp | 2017-12-01 |
| AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (N970012/S139) | Boston Scientific Corp | 2017-11-29 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cord Stimulato (P030017/S295) | Boston Scientific Corp | 2017-11-22 |
| Precision Spinal Cord/ Spectra/Novi Spinal Cord Stimulatior (SCS) System, Precision Montage MRI and Precision Montage Sp (P030017/S296) | Boston Scientific Corp | 2017-11-22 |
| Blazer Open-Irrigated Ablation Catheter System (P150005/S031) | Boston Scientific Corp | 2017-11-21 |
| SMART-MSP (P010012/S464) | Boston Scientific Corp | 2017-11-17 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S148) | Boston Scientific Corp | 2017-11-17 |
| Wolverine Coronary Cutting Balloon (P950020/S087) | Boston Scientific Corp | 2017-11-16 |
| Wolverine Coronary Cutting Balloon (Monorail; Over-theWire) (P950020/S086) | Boston Scientific Corp | 2017-11-15 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S280) | Boston Scientific Corp | 2017-11-14 |
| Epic Vascular Self-Expanding Stent System (P110035/S042) | Boston Scientific Corp | 2017-11-09 |
| Epic Vascular Self-Expanding Stent System (P110035/S043) | Boston Scientific Corp | 2017-11-09 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S081) | Boston Scientific Corp | 2017-11-03 |
| Rotablator Rotational Atherectomy System (P900056/S165) | Boston Scientific Corp | 2017-11-02 |
| Chilli II Cooled RF Ablation System (P980003/S082) | Boston Scientific Corp | 2017-11-01 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and OVer-The-Wire) (P130030/S045) | Boston Scientific Corp | 2017-11-01 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S167) | Boston Scientific Corp | 2017-11-01 |
| Express SD Monorail Premounted Stent System (P060006/S087) | Boston Scientific Corp | 2017-11-01 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (rebrand of PROMUS Element Plus) (P110010/S147) | Boston Scientific Corp | 2017-11-01 |
| Blazer II Cardiac Ablation System (P920047/S105) | Boston Scientific Corp | 2017-11-01 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S030) | Boston Scientific Corp | 2017-11-01 |
| Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S303) | Boston Scientific Corp | 2017-10-31 |
| Precision Montage MRI Spinal Cord Stimulator (SCS) Systems (P030017/S304) | Boston Scientific Corp | 2017-10-31 |
| BSC Wolverine Coronary Cutting Balloon (P950020/S084) | Boston Scientific Corp | 2017-10-27 |
| Autogen, Dynagen, Inogen, Origen - NG3 Cardiac Resynchronization Therapy / Momentum, Vigilant, Resonate - NG4 CRT-D Devi (P010012/S466) | Boston Scientific Corp | 2017-10-26 |
| Altrua, Essentio, Proponent, Accolade - Accolade Non-MRI Pacemakers (N970003/S215) | Boston Scientific Corp | 2017-10-26 |
| Accolade Non-MRI Pacemakers: ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S216) | Boston Scientific Corp | 2017-10-20 |