| Express SD Renal Monorail Premounted Stent System (P060006/S095) | Boston Scientific Corp | 2018-12-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S001) | Boston Scientific Corp | 2018-12-06 |
| Watchman LAA Closure Technology (P130013/S022) | Boston Scientific Corp | 2018-12-04 |
| Blazer II, Blazer II HTD, Blazer Prime HTD (P920047/S113) | Boston Scientific Corp | 2018-11-28 |
| Precision Novi, Montage, Spectra, Spectra WaveWriter Spinal Cord Stimulator System (SCS) (P030017/S321) | Boston Scientific Corp | 2018-11-27 |
| Vercise Deep Brain Stimulation (DBS)System (P150031/S010) | Boston Scientific Corp | 2018-11-26 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord (P030017/S320) | Boston Scientific Corp | 2018-11-23 |
| AMS 700 Implantable Penile Prosthesis with and withoutInhibiZone (N970012/S152) | Boston Scientific Corp | 2018-11-16 |
| ORIGEN, INOGEN, DYNAGEN, AUTOGEN, MOMENTUM, VIGILANT, RESONATE (P010012/S491) | Boston Scientific Corp | 2018-11-16 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA, ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S232) | Boston Scientific Corp | 2018-11-16 |
| AngioJet Rheolytic Thrombectomy System (P980037/S071) | Boston Scientific Corp | 2018-11-06 |
| Epic Vascular Self-Expanding Stent System (P110035/S048) | Boston Scientific Corp | 2018-11-01 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S037) | Boston Scientific Corp | 2018-11-01 |
| Rebel Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S056) | Boston Scientific Corp | 2018-10-31 |
| Wolverine Coronary Cutting Balloon Monorail Over The Wire (P950020/S091) | Boston Scientific Corp | 2018-10-31 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S160) | Boston Scientific Corp | 2018-10-31 |
| AMS 700 Inflatable Penile Prosthesis (IPP) (with and without InhibiZone) (N970012/S146) | Boston Scientific Corp | 2018-10-25 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S097) | Boston Scientific Corp | 2018-10-24 |
| AMS 700 Series Inflatable Penile Prosthesis (IPP) with and without InhibiZone, Ambicor IPP (N970012/S149) | Boston Scientific Corp | 2018-10-24 |
| AMS Sphincter 800 Urinary Control System (P000053/S093) | Boston Scientific Corp | 2018-10-18 |
| Epic Vascular Self-Expanding Stent System (P110035/S047) | Boston Scientific Corp | 2018-10-18 |
| CRT-Ds Autogen, Inogen, Dynagen, Origen, Resonate, Momentum, Vigilant, Perciva, Punctua, Energen, and Incepta (P010012/S490) | Boston Scientific Corp | 2018-10-10 |
| Express SD Renal Monorail Premounted System (P060006/S094) | Boston Scientific Corp | 2018-10-10 |
| Alair Bronchial Thermoplasty Catheter (P080032/S017) | Boston Scientific Corp | 2018-10-05 |
| AngioJet Rheolytic Thrombectomy System, AngioJet Ultra XMI/AngioJet Ultra Spiroflex/AngioJet Ultra Distaflex Thrombectom (P980037/S070) | Boston Scientific Corp | 2018-10-02 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter Spinal Cord (P030017/S319) | Boston Scientific Corp | 2018-09-21 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S092) | Boston Scientific Corp | 2018-09-20 |
| AMS 700 Series Product Line/ Inflatable Penile Prosthesis (IPP) with and without InhibiZone Treatment (N970012/S148) | Boston Scientific Corp | 2018-09-19 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S055) | Boston Scientific Corp | 2018-09-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S040) | Boston Scientific Corp | 2018-09-19 |
| Express SD Monorail Premounted Stent System (P060006/S093) | Boston Scientific Corp | 2018-09-19 |
| PROMUS Element Plus Everolimus-Eluting Stent System/ PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S159) | Boston Scientific Corp | 2018-09-19 |
| Rotablator Rotational Atherectomy System (P900056/S173) | Boston Scientific Corp | 2018-09-19 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S088) | Boston Scientific Corp | 2018-09-19 |
| Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S154) | Boston Scientific Corp | 2018-09-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S111) | Boston Scientific Corp | 2018-09-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011) | Boston Scientific Corp | 2018-09-18 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Spectra WaveWriter SPinal Cor (P030017/S318) | Boston Scientific Corp | 2018-09-15 |
| WOLVERINE Coronary Cutting Balloon Microsurgical Dilation Device (MR) (P950020/S090) | Boston Scientific Corp | 2018-09-14 |
| REBEL Platinum Chromium Coronary Stent System (MR) (P130030/S054) | Boston Scientific Corp | 2018-09-13 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Eeverolimus-Eluting Platinum Chromium Coronary Stent (P110010/S155) | Boston Scientific Corp | 2018-09-07 |
| Express SD Monorail Premounted Stent Systemt (P060006/S091) | Boston Scientific Corp | 2018-09-07 |
| Rotablator Rotational Atherectomy System (P900056/S170) | Boston Scientific Corp | 2018-09-07 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S108) | Boston Scientific Corp | 2018-09-07 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S085) | Boston Scientific Corp | 2018-09-07 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S036) | Boston Scientific Corp | 2018-09-07 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S050) | Boston Scientific Corp | 2018-09-07 |
| Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Origen CRT-D, Origen X4 CRT-D, Autogen CRT-D, Autogen X4 (P010012/S489) | Boston Scientific Corp | 2018-09-04 |
| PROMUS PREMIER Everolimus-Eluting Platinum Chrominum Coronary Stent System (P110010/S151) | Boston Scientific Corp | 2018-08-30 |
| Vercise DBS System / Vercise PC DBS System (P150031/S005) | Boston Scientific Corp | 2018-08-23 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S008) | Boston Scientific Corp | 2018-08-22 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S053) | Boston Scientific Corp | 2018-08-22 |
| MANAGE HF Study (P010012/S486) | Boston Scientific Corp | 2018-08-21 |
| Longitudinal Surveillance Registry of the ACUITY Spiral Lead (P010012/S487) | Boston Scientific Corp | 2018-08-20 |
| Precision, Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI and Precision Spectra WaveWriter (P030017/S317) | Boston Scientific Corp | 2018-08-02 |
| Precision Spectra, Spectra WaveWriter, Precision Montage, and Precision Montage MRI Spinal Cord Stimulatort (SCS) System (P030017/S316) | Boston Scientific Corp | 2018-08-01 |
| Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters (P150005/S035) | Boston Scientific Corp | 2018-08-01 |
| Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI an Spectra WaveWriter SPinal Cord Stimulator (P030017/S315) | Boston Scientific Corp | 2018-08-01 |
| ACUITYX4 Lead Straight, ACUITY X4 Lead Spiral S, ACUITY X4 Lead Spiral L and Suture Sleeve Accessory (P010012/S484) | Boston Scientific Corp | 2018-07-27 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE Pacemaker and Programmer Software Applica (N970003/S229) | Boston Scientific Corp | 2018-07-27 |
| Easytrak 2, Easytrack 3, Acuity Sprial, Acuity X4 (P010012/S488) | Boston Scientific Corp | 2018-07-26 |
| Vercise Deep Brain Stimulation (DBS)System (P150031/S007) | Boston Scientific Corp | 2018-07-25 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S091) | Boston Scientific Corp | 2018-07-23 |
| AMS 700 Implantable Penile Prosthesis with and without InhibiZone (N970012/S147) | Boston Scientific Corp | 2018-07-23 |
| ALTRUA 2, ESSENTIO, PROPONENT and ACCOLADE (N970003/S231) | Boston Scientific Corp | 2018-07-17 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S086) | Boston Scientific Corp | 2018-07-11 |
| PROMUS Element Plus Everolimus-Eluting Stent System/PROMUS PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent S (P110010/S158) | Boston Scientific Corp | 2018-07-11 |
| Express SD Monorail Premounted Stent System (P060006/S092) | Boston Scientific Corp | 2018-07-11 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S052) | Boston Scientific Corp | 2018-07-11 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S038) | Boston Scientific Corp | 2018-07-11 |
| Rotablator Rotational Atherectomy System (P900056/S172) | Boston Scientific Corp | 2018-07-11 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S109) | Boston Scientific Corp | 2018-07-11 |
| ROTAPRO Rotational Atherectomy System (P900056/S171) | Boston Scientific Corp | 2018-07-02 |
| Epic Vascular Self-Expanding Stent System (P110035/S046) | Boston Scientific Corp | 2018-06-28 |
| Precision Spinal cord Stimulator System, Precision spectra Spinal cord Stimulator System, Spectra WaveWriter Spinal cord (P030017/S314) | Boston Scientific Corp | 2018-06-25 |
| PROMUS Element Plus/Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S157) | Boston Scientific Corp | 2018-06-21 |
| Vercise Deep Brain Stimulation (DBS) System (P150031/S006) | Boston Scientific Corp | 2018-06-19 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D), Dynagen CRT-D/X4 CRT-D, Inogen CRT-D/X4 CRT-D, Origen CRT-D/X4 (P010012/S485) | Boston Scientific Corp | 2018-06-01 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S051) | Boston Scientific Corp | 2018-05-22 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S156) | Boston Scientific Corp | 2018-05-22 |
| Rebel Platinum Chromium Coronary Stent System (Monorail) (P130030/S049) | Boston Scientific Corp | 2018-05-21 |
| Watchman Left Atrial Appendage Closure Technology (P130013/S019) | Boston Scientific Corp | 2018-05-18 |
| Acuity Spiral Lead Family, Acuity X4 Lead Family (P010012/S483) | Boston Scientific Corp | 2018-05-16 |
| AMS 800 Urinary Control System with and without InhibiZone (P000053/S090) | Boston Scientific Corp | 2018-05-14 |
| AMS 800 Urinary Control System with and without Inhibizone (P000053/S089) | Boston Scientific Corp | 2018-05-11 |
| Precision Spinal Cord Stimulator System (P030017/S313) | Boston Scientific Corp | 2018-04-26 |
| Contak CD,Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S482) | Boston Scientific Corp | 2018-04-25 |
| Pulsar/Pulsar Max Implantable Pulse Generator System with Consult Software (N970003/S228) | Boston Scientific Corp | 2018-04-25 |
| Vercise DBS System (P150031/S003) | Boston Scientific Corp | 2018-04-24 |
| Accolade, Altrua 2, Essentio, Proponent (N970003/S227) | Boston Scientific Corp | 2018-04-11 |
| Ambicor Inflatable Penile Prosthesis (IPP), AMS 700 IPP (N970012/S145) | Boston Scientific Corp | 2018-04-06 |
| Epic Vascular Self-Expanding Stent System (P110035/S045) | Boston Scientific Corp | 2018-04-03 |
| Precision Spectra WaveWriter Spinal Cord Stimulator Systems, Precision Spectra, Pre-Weld Test Equipment System (P030017/S312) | Boston Scientific Corp | 2018-04-02 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen, Resonate, Momentum, Vigiliant, Perciva (P010012/S477) | Boston Scientific Corp | 2018-03-26 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent (N970003/S224) | Boston Scientific Corp | 2018-03-26 |
| RSONATE, MOMENTUM and VIGILANT NG4 CRT-DS (P010012/S480) | Boston Scientific Corp | 2018-03-22 |
| ROTAPRO Advancer; ROTAPRO; ROTAPRO Console (P900056/S166) | Boston Scientific Corp | 2018-03-19 |
| WATCHMAN Left Atrial Appendage CLosure (LAAC) Device with Delivery System (P130013/S018) | Boston Scientific Corp | 2018-03-19 |
| Wolverine Coronary Cutting Balloon Monorail (MR) and Over-the-Wire (OTW) (P950020/S089) | Boston Scientific Corp | 2018-03-16 |
| Carotid WALLSTENT (P050019/S030) | Boston Scientific Corp | 2018-03-13 |