| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S143) | Boston Scientific Corp | 2017-08-17 |
| Rotablator Rotational Atherectomy System (P900056/S163) | Boston Scientific Corp | 2017-08-17 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S023) | Boston Scientific Corp | 2017-08-17 |
| REBEL Platinum CHromum Coronary Stent System (P130030/S042) | Boston Scientific Corp | 2017-08-17 |
| Express SD Monorail Premounted Stent System (P060006/S084) | Boston Scientific Corp | 2017-08-17 |
| Chilli II Coole dAblation Catheter and Cable (P980003/S077) | Boston Scientific Corp | 2017-08-17 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S100) | Boston Scientific Corp | 2017-08-17 |
| AMS 700 Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S137) | Boston Scientific Corp | 2017-08-11 |
| PrecisionTM and Spectra WaveWriterTM Spinal Cord Stimulation (SCS) Systems (P030017/S275) | Boston Scientific Corp | 2017-08-11 |
| Terminal Pin Weld Process Monitoring Plan (P010012/S457) | Boston Scientific Corp | 2017-08-08 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S452) | Boston Scientific Corp | 2017-08-07 |
| CRT-D Resynchronization Devices COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, (P010012/S450) | Boston Scientific Corp | 2017-08-07 |
| ADVANTIO, INGENIO, VITALO, FORMIO, ESSENTO, ACCOLADE, PROPONENT Families of Pacemaker Devices (N970003/S207) | Boston Scientific Corp | 2017-08-07 |
| Precision Spectra Wavewriter Spinal Cord Stimulatror (SCS) System (P030017/S291) | Boston Scientific Corp | 2017-08-03 |
| Rebel Platinum Chromium Coronary Stent System (Monorail) and (Over-the-Wire). (P130030/S040) | Boston Scientific Corp | 2017-08-01 |
| AMBICOR INFLATABLE PENILE PROSTHESIS (N970012/S127) | Boston Scientific Corp | 2017-07-28 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System (P130013/S014) | Boston Scientific Corp | 2017-07-27 |
| BLAZER OPEN-IRRIGATED ABLATION CATHETER (P150005/S011) | Boston Scientific Corp | 2017-07-27 |
| Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A (P010012/S454) | Boston Scientific Corp | 2017-07-25 |
| Express® SD Monorail® Premounted Stent System (P060006/S083) | Boston Scientific Corp | 2017-07-24 |
| Blazer (II, II HTD, Primie HTD) (P920047/S098) | Boston Scientific Corp | 2017-07-24 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S022) | Boston Scientific Corp | 2017-07-24 |
| ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS (P010012/S443) | Boston Scientific Corp | 2017-07-24 |
| Chilli II TM Cooled Ablation Catheter and Cable (P980003/S076) | Boston Scientific Corp | 2017-07-24 |
| REBEL TM Platinum Chromium Coronary Stent System (P130030/S041) | Boston Scientific Corp | 2017-07-24 |
| Chilli Cooled RF Ablation System (P980003/S074) | Boston Scientific Corp | 2017-07-24 |
| Blazer IITM Cardiac Ablation Catheter and Cable (P920047/S099) | Boston Scientific Corp | 2017-07-24 |
| PROMUS Element Plus Everolimus-Eiuting Stent System I, PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary (P110010/S142) | Boston Scientific Corp | 2017-07-24 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S020) | Boston Scientific Corp | 2017-07-24 |
| Rotablator® Rotational Atherectomy System (P900056/S162) | Boston Scientific Corp | 2017-07-24 |
| Precision Montage (MRI) Spinal COrd Stimulation (SCS) System (P030017/S299) | Boston Scientific Corp | 2017-07-19 |
| AMBICOR INFLATABLE PENILE PROSTHESES (N970012/S126) | Boston Scientific Corp | 2017-07-13 |
| Precision Spectra / Novi / Wavewriter Spinal Cord Stimulator (SCS) System, Precision Montage Spinal Cord Stimulator (SCS (P030017/S298) | Boston Scientific Corp | 2017-07-12 |
| Rotational Atherectomy System (P900056/S157) | Boston Scientific Corp | 2017-07-05 |
| Carotid Wallstent Monorail Endoprothesis plus delivery system (P050019/S028) | Boston Scientific Corp | 2017-07-03 |
| Wallstent (Tips) Endoprosthesis with unistep plus delivery system (P930031/S060) | Boston Scientific Corp | 2017-07-03 |
| EASYTRACK 2 Lead, ACUITY Spiral Lead (P010012/S456) | Boston Scientific Corp | 2017-06-30 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S059) | Boston Scientific Corp | 2017-06-28 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S455) | Boston Scientific Corp | 2017-06-26 |
| Precision Spectra Spinal Cord Stimulator (SCS) System (P030017/S294) | Boston Scientific Corp | 2017-06-21 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) - Origne: G050, G051, G056, G058 - Inogen: G140, G141, G146, G14 (P010012/S451) | Boston Scientific Corp | 2017-06-21 |
| Precision Montage and Precision Montage MRI Spinal Cord Stimulator System (P030017/S293) | Boston Scientific Corp | 2017-06-21 |
| Precision Spectra and Spectra WaveWriter Spinal Cord Stimulator (P030017/S292) | Boston Scientific Corp | 2017-06-19 |
| Ambicor Implantable Penile Prosthesis (N970012/S135) | Boston Scientific Corp | 2017-06-16 |
| Epic Vascular Self-Expanding Stent System (P110035/S041) | Boston Scientific Corp | 2017-06-16 |
| AMS 700 SERIES PRODUCT LINE AND THE DYNAFLEX INFLATABLE PENILE PROSTHESIS (N970012/S114) | Boston Scientific Corp | 2017-06-15 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S062) | Boston Scientific Corp | 2017-06-15 |
| Chilli II Cooled Ablation Catheter (P980003/S075) | Boston Scientific Corp | 2017-06-13 |
| Blazer Open-Irrigated Ablation Catheter, IntellaNav Open-Irrigated Ablation Catheter, Intella Tip MiFi Open-Irrigated Ab (P150005/S021) | Boston Scientific Corp | 2017-06-13 |
| AMS 800 Urinary Control System (P000053/S079) | Boston Scientific Corp | 2017-06-09 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) ORIGEN, INOGEN, DYNAGEN, AUTOGEN, PUNCTUA, ENERGEN, INCEPTA, MOM (P010012/S449) | Boston Scientific Corp | 2017-06-06 |
| Precision Novi Spinal Cord Stimulator (SCS) System (P030017/S287) | Boston Scientific Corp | 2017-06-06 |
| AngioJet Rheolytic Thrombectomy System (P980037/S065) | Boston Scientific Corp | 2017-06-02 |
| Precision Spinal Cord Stimulation (SCS) System (P030017/S288) | Boston Scientific Corp | 2017-06-01 |
| PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM (P030017/S269) | Boston Scientific Corp | 2017-05-31 |
| Epic Vascular Self-Expanding Stent System (P110035/S040) | Boston Scientific Corp | 2017-05-26 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S161) | Boston Scientific Corp | 2017-05-26 |
| Cardiac Resynchronization Therapy Defibrillator; Dynagen, Inogen, Origen, Autogen CRT-D's (P010012/S446) | Boston Scientific Corp | 2017-05-18 |
| Express SD Monorail® Premounted Stent System (P060006/S082) | Boston Scientific Corp | 2017-05-12 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S019) | Boston Scientific Corp | 2017-05-12 |
| PROMUS Element Plus Everolimus-Eiuting Stent System (P110010/S141) | Boston Scientific Corp | 2017-05-12 |
| PRECISION SPECTRA SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S273) | Boston Scientific Corp | 2017-05-12 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S039) | Boston Scientific Corp | 2017-05-12 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S073) | Boston Scientific Corp | 2017-05-12 |
| Blazer II TM Cardiac Ablation Catheter and Cable (P920047/S097) | Boston Scientific Corp | 2017-05-12 |
| Rotablator® Rotational Atherectomy System (P900056/S160) | Boston Scientific Corp | 2017-05-12 |
| Spectra WaveWriter Spinal Cord Stimulator System (P030017/S290) | Boston Scientific Corp | 2017-05-11 |
| Epic Vascular Self-Expanding Stent System (P110035/S039) | Boston Scientific Corp | 2017-05-10 |
| Express SD Renal Stent System (P060006/S081) | Boston Scientific Corp | 2017-05-10 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S140) | Boston Scientific Corp | 2017-05-10 |
| Rebel Platinum Chromium Coronary Stent System Monorail and Over The Wire (P130030/S038) | Boston Scientific Corp | 2017-05-10 |
| Wolverine Coronary Cutting Balloon (P950020/S080) | Boston Scientific Corp | 2017-05-10 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter Spinal Cor (P030017/S289) | Boston Scientific Corp | 2017-05-10 |
| Precision Montage MRI and Precision Montage Spinal Cord Stimulator (SCS)Systems (P030017/S281) | Boston Scientific Corp | 2017-05-08 |
| IntellaNav Ol (P150005/S015) | Boston Scientific Corp | 2017-05-08 |
| AMS 700 Implantable Penile Prosthesis with and without Inhibizone Treatment (N970012/S131) | Boston Scientific Corp | 2017-05-08 |
| Rotablator Rotational Atherectomy System (P900056/S159) | Boston Scientific Corp | 2017-05-04 |
| NG4 Family of Pulse Generators CRT-DS (P010012/S436) | Boston Scientific Corp | 2017-05-02 |
| Pacemaker Models Advantio & Ingenio (N970003/S205) | Boston Scientific Corp | 2017-05-01 |
| Essento, Proponent, Accolade, Altrua (N970003/S206) | Boston Scientific Corp | 2017-05-01 |
| AMS 700 Implantable Penile Prosthesis with InhibiZone Treatment, AMS 700 Implantable Penile Prosthesis without InhibiZon (N970012/S134) | Boston Scientific Corp | 2017-04-28 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S278) | Boston Scientific Corp | 2017-04-28 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S075) | Boston Scientific Corp | 2017-04-28 |
| AngioJet Ultra Thrombecomy System Conosle (P980037/S064) | Boston Scientific Corp | 2017-04-27 |
| AMS 700 Implanted Penile Prosthesis (N970012/S128) | Boston Scientific Corp | 2017-04-27 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-D Resynchronization Devices (P010012/S445) | Boston Scientific Corp | 2017-04-21 |
| MetriQ Irrigation Pump (P150005/S013) | Boston Scientific Corp | 2017-04-20 |
| ENDOTAK RELIANCE IS-1 and ENDOTAK RELIANCE 4-SITE Lead (P010012/S447) | Boston Scientific Corp | 2017-04-19 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA AND ALTRUA 2 PACEMAKER's (N970003/S197) | Boston Scientific Corp | 2017-04-17 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT CRT-D's Resynchroniza (P010012/S435) | Boston Scientific Corp | 2017-04-17 |
| Ambicor Inflatable Penile Prosthesis. (N970012/S133) | Boston Scientific Corp | 2017-04-14 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S013) | Boston Scientific Corp | 2017-04-13 |
| PROMUS(ELEMENT PLUS/PREMIER) EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P110010/S139) | Boston Scientific Corp | 2017-04-11 |
| IntellaNav Open Irrigated Ablation Catheter (P150005/S018) | Boston Scientific Corp | 2017-04-07 |
| AMS 700 Penile Prosthesis (N970012/S129) | Boston Scientific Corp | 2017-04-07 |
| AMS SPHINCTER 800 URINARY CONTROL SYSTEM (P000053/S076) | Boston Scientific Corp | 2017-04-07 |
| AMS 700 Inflatable Penile Prosthesis (with and without Inhibizone Treatment) (N970012/S132) | Boston Scientific Corp | 2017-04-06 |
| AMS 800 Urinary Control System Product Line (P000053/S078) | Boston Scientific Corp | 2017-04-06 |
| AMS 800 Urinary Control System (P000053/S077) | Boston Scientific Corp | 2017-03-29 |
| ESSENTIO Models: L100, L101, L121; PROPONENT Models: L200, L201, L221; ACCOLADE Models: L300, L301, L321; ALTRUA 2 Model (N970003/S203) | Boston Scientific Corp | 2017-03-29 |