| Altrua / Essentio / Proponent / Accolade / Accolade Non-MRI Pacemakers (N970003/S214) | Boston Scientific Corp | 2017-10-18 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S279) | Boston Scientific Corp | 2017-10-17 |
| AngioJet Ultra XMI / Spiroflex / Spiroflex VG / Distaflex Thrombectomy Set (P980037/S066) | Boston Scientific Corp | 2017-10-16 |
| Chilli II (P980003/S080) | Boston Scientific Corp | 2017-10-11 |
| Blazer OI / IntellaNav OI / Intella Tip MiFi OI (P150005/S028) | Boston Scientific Corp | 2017-10-11 |
| Blazer II HTD / Blazer Prime HTD (P920047/S103) | Boston Scientific Corp | 2017-10-11 |
| CRT-Ds: DYNAGEN, VIGILANT, MOMENTUM (P010012/S463) | Boston Scientific Corp | 2017-10-11 |
| AMS 700 Series Product Line / Implantable Penile Prosthesis with and without InhibiZone Treatment (N970012/S138) | Boston Scientific Corp | 2017-10-06 |
| Chilli II Cooled Ablation System (P980003/S081) | Boston Scientific Corp | 2017-10-06 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Ablation Catheter (P150005/S029) | Boston Scientific Corp | 2017-10-06 |
| AngioJet Ultra Thrombectomy System (P980037/S067) | Boston Scientific Corp | 2017-09-28 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE; Implantable Cardiac Resynchronization Therapy Defibrilla (P010012/S461) | Boston Scientific Corp | 2017-09-28 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S015) | Boston Scientific Corp | 2017-09-28 |
| AMS 800 Artificial Urinary Sphincter (P000053/S080) | Boston Scientific Corp | 2017-09-26 |
| AMS 700 and Ambicor Inflatable Penile Prosthesis (N970012/S136) | Boston Scientific Corp | 2017-09-26 |
| Blazer II HTD, Blazer Prime HTD (P920047/S102) | Boston Scientific Corp | 2017-09-26 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI (P150005/S027) | Boston Scientific Corp | 2017-09-26 |
| Chill II (P980003/S079) | Boston Scientific Corp | 2017-09-26 |
| CRT-Ds: Origen, Momentum, Inogen, Dynagen, Autogen, Vigilant, Resonate, Punctua, Energen and Incepta (P010012/S462) | Boston Scientific Corp | 2017-09-25 |
| Pacemakers: Advantio, Ingenio, Vitalio, Formio, Essentio, Proponent, Accolade, and Altrua 2 (N970003/S212) | Boston Scientific Corp | 2017-09-25 |
| Promus Element plus Everolimus Eluting Platinum Chromium Coronary Stent System Monorail and over the wire/ Promus Premie (P110010/S146) | Boston Scientific Corp | 2017-09-22 |
| ALTRUA 2 /ESSENTIO/ PROPONENT/ ACCOLADE (N970003/S209) | Boston Scientific Corp | 2017-09-21 |
| RESONATE, VIGILANT NG4 CRT-Ds, AUTOGEN, DYNAGEN, INOGEN, ORIGEN NG3 CRT-Ds, ACUITY X4 Leads, Slit Suture Sleeve Accesso (P010012/S453) | Boston Scientific Corp | 2017-09-20 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S083) | Boston Scientific Corp | 2017-09-18 |
| Blazer OI and IntellaNav OI (P150005/S026) | Boston Scientific Corp | 2017-09-15 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S082) | Boston Scientific Corp | 2017-09-14 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S145) | Boston Scientific Corp | 2017-09-13 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S044) | Boston Scientific Corp | 2017-09-13 |
| Express SD Renal Premounted Stent System (P060006/S086) | Boston Scientific Corp | 2017-09-13 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent, Altrua 2 Pacemakers (N970003/S204) | Boston Scientific Corp | 2017-09-11 |
| Torque Wrench (N970003/S208) | Boston Scientific Corp | 2017-09-11 |
| Torque Wrench (P010012/S458) | Boston Scientific Corp | 2017-09-11 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-Ds (P010012/S448) | Boston Scientific Corp | 2017-09-11 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S277) | Boston Scientific Corp | 2017-09-08 |
| Flextome Cutting Balloon Microsurgical Dilation Device (P950020/S083) | Boston Scientific Corp | 2017-09-07 |
| Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI (P150005/S025) | Boston Scientific Corp | 2017-09-06 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S164) | Boston Scientific Corp | 2017-08-31 |
| Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S043) | Boston Scientific Corp | 2017-08-31 |
| Express SD Monorail Premounted Stent System (P060006/S085) | Boston Scientific Corp | 2017-08-31 |
| Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire) (P950020/S082) | Boston Scientific Corp | 2017-08-31 |
| Chilli II Cooled RF Ablation system (P980003/S078) | Boston Scientific Corp | 2017-08-31 |
| Blazer II Cardiac Ablation System (P920047/S101) | Boston Scientific Corp | 2017-08-31 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S144) | Boston Scientific Corp | 2017-08-31 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S024) | Boston Scientific Corp | 2017-08-31 |
| Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage, Precision Montage, MRI Spinal Cord Stimulator (P030017/S301) | Boston Scientific Corp | 2017-08-31 |
| Accolade Non-MRI Pacemakers , Altrua, Essentio, Proponent, Accolade (N970003/S210) | Boston Scientific Corp | 2017-08-30 |
| NG3 Cardiac Resynchronization Therapy- Defibrillator Devices , Autogen Dynagen, Inogen, Origen , Momentum, Vigilant, Res (P010012/S459) | Boston Scientific Corp | 2017-08-30 |
| CRT-Ds: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, VIGILANT, MOMENTUM, RESONATE, PUNCTUA, ENERGEN, INCEPTA (P010012/S460) | Boston Scientific Corp | 2017-08-30 |
| PRECISION SPINAL CORD STIMULATION(SCS) SYSTEM (P030017/S270) | Boston Scientific Corp | 2017-08-30 |
| Pacemakers: ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S211) | Boston Scientific Corp | 2017-08-30 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S017) | Boston Scientific Corp | 2017-08-22 |
| Flextome Cutting Balloon Microsurgical Dilatation Device/Wolverine Coronary Cutting Balloon Monorail (MR) / Wolverine Co (P950020/S081) | Boston Scientific Corp | 2017-08-18 |
| 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 |