| Ventak AV AICD Ventak Prizm DR/VR, Vitality, Cofient, and Teligen Automatic Implantable Cardioverter Defibrillator Syste (P960040/S461) | Boston Scientific | 2020-12-11 |
| Attain StarFix Lead (P060039/S103) | Medtronic, Inc. | 2020-12-10 |
| SelectSecure Lead (P030036/S125) | Medtronic Cardiac Rhythm Disease Management | 2020-12-10 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S668) | Medtronic, Inc. | 2020-12-10 |
| Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves (P040021/S045) | ABBOTT MEDICAL | 2020-12-10 |
| Sprint Quattro Lead (P920015/S251) | Medtronic, Inc. | 2020-12-10 |
| CapSure Sense Lead (P830061/S190) | Medtronic Cardiac Rhythm Disease Management | 2020-12-10 |
| CapSureFix Novus Lead (P930039/S221) | Medtronic, Inc. | 2020-12-10 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S031) | Cardiovascular Systems, Inc. | 2020-12-10 |
| Edwards Commander Delivery System (P200015/S006) | Edwards Lifesciences, LLC | 2020-12-10 |
| Angio Seal Vascular Closure Device (P930038/S098) | Terumo Medical Corporation | 2020-12-09 |
| Attain StarFix Lead (P060039/S105) | Medtronic, Inc. | 2020-12-08 |
| DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS (P920015/S250) | Medtronic, Inc. | 2020-12-08 |
| CapSure Epicardial Pacing Lead (P950024/S097) | Medtronic, Inc. | 2020-12-08 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S155) | Medtronic, Inc. | 2020-12-08 |
| Transvene CS/SVC Lead (P980050/S131) | Medtronic, Inc. | 2020-12-08 |
| Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead (P830061/S188) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S462) | Medtronic, Inc. | 2020-12-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S030) | Medinol, Ltd. | 2020-12-08 |
| Innova Vascular Self-Expanding Stent System (P140028/S065) | Boston Scientific Corporation | 2020-12-08 |
| End Cap, Epicardial Patch Lead, and Upsizing Sleeve (P900061/S163) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S186) | Boston Scientific Corp | 2020-12-08 |
| Attain Ability Lead (P080006/S154) | Medtronic, Inc. | 2020-12-08 |
| Myocardial Pacing Lead (P120017/S026) | Medtronic, Inc. | 2020-12-08 |
| CapSureFix MRI Lead (P090013/S312) | Medtronic, Inc. | 2020-12-08 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead (P930039/S219) | Medtronic, Inc. | 2020-12-08 |
| Evolut R, Pro and Pro+ Systems (P130021/S083) | Medtronic, Inc. | 2020-12-08 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S039) | Boston Scientific Corp | 2020-12-08 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S069) | Boston Scientific Corporation | 2020-12-08 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le (P850089/S152) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S128) | Medtronic Cardiac Rhythm Disease Management | 2020-12-08 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S441) | Medtronic, Inc. | 2020-12-08 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S071) | Boston Scientific Corp | 2020-12-08 |
| X Series, R Series, and AED Pro (P160022/S023) | ZOLL Medical Corporation | 2020-12-07 |
| Avalus Bioprosthesis (P170006/S019) | Medtronic, Inc. | 2020-12-06 |
| GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S081) | W. L. Gore & Associates, Inc. | 2020-12-04 |
| StarClose SE Vascular Closure System (P050007/S040) | Abbott Vascular Devices | 2020-12-04 |
| Prostar XL Percutaneous Vascular Surgical System, Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Su (P960043/S110) | Abbott Vascular, Inc. | 2020-12-04 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S456) | Boston Scientific | 2020-12-04 |
| GORE CARDIOFORM Septal Occluder (P050006/S087) | W. L. Gore & Associates, Inc. | 2020-12-04 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S525) | Boston Scientific Corp | 2020-12-04 |
| ENDOTAK LEAD SYSTEM (P910073/S158) | Boston Scientific | 2020-12-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S050) | Medtronic, Inc. | 2020-12-04 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S248) | Medtronic, Inc. | 2020-12-03 |
| SelectSecure Lead (P030036/S126) | Medtronic Cardiac Rhythm Disease Management | 2020-12-03 |
| TREO® Abdominal Stent-Graft System (P190015/S004) | Bolton Medical, Inc. | 2020-12-03 |
| Preveleak Surgical Sealant - 1O-Pack Delivery Tips (P100030/S014) | Baxter Healthcare Corporation | 2020-12-02 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S001) | Boston Scientific Corporation | 2020-12-02 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, and Intica Neo 5 (P980023/S103) | Biotronik, Inc. | 2020-12-01 |
| Ilivia Neo 7 DR-T, Intica Neo 7 DR-T, and Intica Neo 5 DR-T (P000009/S088) | Biotronik, Inc. | 2020-12-01 |
| Tupos LV/ATx and Kronos LV-T CRT-D System (P050023/S152) | Biotronik, Inc. | 2020-12-01 |
| Dromos DR/SR Rate Adaptive Pacing Systems (P950037/S217) | Biotronik, Inc. | 2020-12-01 |
| Etrinsa 8 HF-T, Epyra 8 HF-T, and Eluna 8 HF-T (P070008/S120) | Biotronik, Inc. | 2020-12-01 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S148) | Boston Scientific Corporation | 2020-12-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S038) | Boston Scientific Corp | 2020-11-30 |
| Epic Self Expanding Stent System (P110035/S063) | Boston Scientific Corp | 2020-11-30 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S183) | Boston Scientific Corp | 2020-11-30 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S066) | Boston Scientific Corporation | 2020-11-30 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S662) | Medtronic, Inc. | 2020-11-25 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S457) | Medtronic, Inc. | 2020-11-25 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S080) | W. L. Gore & Associates, Inc. | 2020-11-25 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S661) | Medtronic, Inc. | 2020-11-24 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S008) | Medtronic Vascular, Inc. | 2020-11-24 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S029) | Medinol, Ltd. | 2020-11-24 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S054) | Medtronic, Inc. | 2020-11-24 |
| HeartWare Ventricular Assist System (P100047/S159) | Medtronic | 2020-11-23 |
| Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System (P900056/S191) | Boston Scientific Corp | 2020-11-23 |
| WOLVERINE Cutting Balloon Micro-Surgical Dilation Catheter (P950020/S110) | Boston Scientific Corp | 2020-11-20 |
| Cardiac Resynchronization Therapy (CRT) (P030054/S387) | ABBOTT MEDICAL | 2020-11-20 |
| AtriCure Synergy Ablation System (P100046/S011) | AtriCure, Inc. | 2020-11-20 |
| Tendril MRI (P140033/S062) | ABBOTT MEDICAL | 2020-11-20 |
| TherOx DownStream System (P170027/S001) | Zoll Circulation, Inc. | 2020-11-20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Sten (P150003/S067) | Boston Scientific Corporation | 2020-11-19 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Coro (P110010/S184) | Boston Scientific Corp | 2020-11-19 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S017) | Celonova Biosciences, Inc. | 2020-11-19 |
| Express SD Renal Premounted Stent System (P060006/S102) | Boston Scientific Corp | 2020-11-18 |
| CapSureFix MRI Lead (P090013/S310) | Medtronic, Inc. | 2020-11-18 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S003) | Defibtech, LLC | 2020-11-18 |
| CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead (P830061/S186) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Express LD Iliac Premounted Stent System (P090003/S050) | Boston Scientific Corporation | 2020-11-18 |
| Micra AV TPS and Micra TPS (P150033/S087) | Medtronic, Inc. | 2020-11-18 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S152) | Medtronic, Inc. | 2020-11-18 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S721) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| SelectSecure Lead (P030036/S124) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S455) | Medtronic, Inc. | 2020-11-18 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S217) | Medtronic, Inc. | 2020-11-18 |
| HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS/SVC (P920015/S247) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve (P980016/S760) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| LifeVest Wearable Defibrillator (P010030/S143) | Zoll Manufacturing Corporation | 2020-11-18 |
| CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer and Vitatron Brilliant S+ VDD Lead (P890003/S436) | Medtronic, Inc. | 2020-11-18 |
| Myocardial Pacing Lead (P120017/S024) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera (P980016/S758) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S015) | Heartsine Technologies, Ltd. | 2020-11-18 |
| Attain StarFix Lead (P060039/S102) | Medtronic, Inc. | 2020-11-18 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D (P010031/S722) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S658) | Medtronic, Inc. | 2020-11-18 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead (P850089/S150) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| CapSure Epicardial Pacing Lead (P950024/S095) | Medtronic, Inc. | 2020-11-18 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt (P010031/S719) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S761) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |