| Impella RP System (P170011/S032) | Abiomed, Inc. | 2021-06-28 |
| Zoll AED 3 and Zoll AED 3 Automatic (P160015/S005) | ZOLL Medical Corporation | 2021-06-28 |
| HeartWare Ventricular Assist System (P100047/S178) | Medtronic | 2021-06-28 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S080) | Abiomed, Inc. | 2021-06-28 |
| ZOLL AED 3 BLS Device (P160022/S019) | ZOLL Medical Corporation | 2021-06-28 |
| Impella RP System (P170011/S026) | Abiomed, Inc. | 2021-06-28 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S186) | ABBOTT MEDICAL | 2021-06-28 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S437) | ABBOTT MEDICAL | 2021-06-28 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S392) | ABBOTT MEDICAL | 2021-06-28 |
| Impella RP with SmartAssist System (P170011/S030) | Abiomed, Inc. | 2021-06-28 |
| Orchestra, Orchestra Plus, and Smart Touch programmers (P980049/S142) | MicroPort CRM USA, Inc. | 2021-06-25 |
| Micra VR TPS (P150033/S111) | Medtronic, Inc. | 2021-06-25 |
| XIENCE Alpine Everolimus Eluting Coronary Stent Systems (XIENCE Alpine EECSS), XIENCE Sierra Everolimus Eluting Coronary (P110019/S115) | Abbott Vascular | 2021-06-25 |
| Alizea and Celea Pacemakers (P950029/S130) | MicroPort CRM USA, Inc. | 2021-06-25 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) (P130026/S074) | St Jude Medical | 2021-06-25 |
| FlexAbility Ablation Catheter (FlexAbility) and FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) (P110016/S077) | ABBOTT MEDICAL | 2021-06-25 |
| Rotablator Rotational Atherectomy System (Rotablator, RotaLink Plus, Rotalink Burr), ROTAPRO Rotational Atherectomy Syst (P900056/S192) | Boston Scientific Corp | 2021-06-24 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S007) | Biotronik AG | 2021-06-24 |
| Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S255) | Medtronic, Inc. | 2021-06-23 |
| Attain StarFix Lead (P060039/S107) | Medtronic, Inc. | 2021-06-23 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S161) | Medtronic, Inc. | 2021-06-23 |
| HeartWare Ventricular Assist System (P100047/S182) | Medtronic | 2021-06-23 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S477) | Medtronic, Inc. | 2021-06-23 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S027) | Physio-Control, Inc. | 2021-06-23 |
| CapSureFix MRI Lead (P090013/S315) | Medtronic, Inc. | 2021-06-23 |
| Transvene CS/SVC Lead (P980050/S133) | Medtronic, Inc. | 2021-06-23 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead (P930039/S228) | Medtronic, Inc. | 2021-06-23 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S446) | Medtronic, Inc. | 2021-06-23 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead (P830061/S195) | Medtronic Cardiac Rhythm Disease Management | 2021-06-23 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S155) | Medtronic Cardiac Rhythm Disease Management | 2021-06-23 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S015) | Abbott Vascular | 2021-06-22 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S026) | Physio-Control, Inc. | 2021-06-22 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S224) | Biotronik, Inc. | 2021-06-22 |
| AngelMed Guardian System (P150009/S002) | Avertix Medical, Inc. | 2021-06-21 |
| HeartWare Ventricular Assist System (P100047/S181) | Medtronic | 2021-06-21 |
| Multi-Link RX Ultra Coronary Stent System (P970020/S085) | Abbott Vascular, Inc. | 2021-06-21 |
| Micra AV TPS and Micra TPS (P150033/S102) | Medtronic, Inc. | 2021-06-21 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S014) | Abbott Vascular | 2021-06-21 |
| Micra AV TPS (P150033/S110) | Medtronic, Inc. | 2021-06-21 |
| Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter (P100010/S110) | Medtronic Cryocath, LP | 2021-06-18 |
| Micra AV TPS, Micra TPS (P150033/S104) | Medtronic, Inc. | 2021-06-17 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S096) | Medtronic, Inc. | 2021-06-17 |
| AFX2 Endovascular AAA System (P040002/S068) | Endologix, LLC | 2021-06-17 |
| 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/S784) | Medtronic Cardiac Rhythm Disease Management | 2021-06-16 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S036) | Medinol, Ltd. | 2021-06-16 |
| 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/S683) | Medtronic, Inc. | 2021-06-16 |
| Micra AV TPS, Micra TPS (P150033/S108) | Medtronic, Inc. | 2021-06-16 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S474) | Medtronic, Inc. | 2021-06-16 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S129) | W. L. Gore & Associates, Inc. | 2021-06-16 |
| 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/S746) | Medtronic Cardiac Rhythm Disease Management | 2021-06-16 |
| Acculink Carotid Stent System (P040012/S061) | Abbott Vascular | 2021-06-16 |
| HeartStart FR3 Defibrillator (P160028/S004) | Philips Medical Systems, Inc. | 2021-06-15 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S012) | Philips Medical Systems, Inc. | 2021-06-15 |
| StarClose SE Vascular Closure System (P050007/S041) | Abbott Vascular Devices | 2021-06-15 |
| HeartStart FRx Defibrillator (P180028/S008) | Philips Medical Systems | 2021-06-15 |
| Impella RP System (P170011/S029) | Abiomed, Inc. | 2021-06-15 |
| HeartStart FRx Defibrillator (P180028/S009) | Philips Medical Systems | 2021-06-15 |
| VenaSeal Closure System (P140018/S024) | Medtronic Vascular, Inc. | 2021-06-15 |
| Powerheart G5 AED (P160033/S008) | ZOLL Medical Corporation | 2021-06-14 |
| EMBLEM S-ICD Lead (P110042/S154) | Boston Scientific Corporation | 2021-06-10 |
| Defibtech's Automated External Defibrillator (AED) System (P160032/S005) | Defibtech, LLC | 2021-06-10 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S114) | Medtronic Cryocath, LP | 2021-06-10 |
| HeartMate 3 Left Ventricular Assist System (P160054/S037) | ABBOTT MEDICAL | 2021-06-10 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (P200030/S003) | W. L. Gore and Associates, Inc. | 2021-06-09 |
| HeartWare HVAD System (P100047/S180) | Medtronic | 2021-06-09 |
| HeartWare Left Ventricular Assist System (P100047/S177) | Medtronic | 2021-06-09 |
| MISAGO RX Self-expanding Peripheral Stent System (P140002/S021) | Terumo Medical Corporation | 2021-06-09 |
| RELIANCE 4-FRONT Steroid-eluting Pace/Sense and Defibrillation Lead (P910073/S162) | Boston Scientific | 2021-06-08 |
| LIFEPAK® CR2 Defibrillator (P170018/S013) | Physio-Control, Inc. | 2021-06-08 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S016) | Heartsine Technologies, Ltd. | 2021-06-08 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S002) | Shockwave Medical, Inc. | 2021-06-04 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bip (P010015/S476) | Medtronic, Inc. | 2021-06-04 |
| 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/S785) | Medtronic Cardiac Rhythm Disease Management | 2021-06-04 |
| Micra AV TPS, Micra TPS (P150033/S109) | Medtronic, Inc. | 2021-06-04 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S685) | Medtronic, Inc. | 2021-06-04 |
| 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/S748) | Medtronic Cardiac Rhythm Disease Management | 2021-06-04 |
| Lutonix 018 and 035 Drug Coated Balloon PTA Catheter (P170003/S021) | Lutonix | 2021-06-03 |
| Lutonix 018 and 035 Drug Coated Balloon (P130024/S040) | Lutonix | 2021-06-03 |
| Covera Vascular Covered Stent (P170042/S009) | C.R. Bard, Inc. | 2021-06-03 |
| Venovo Venous Stent System (P180037/S005) | Bard Peripheral Vascular, Inc. | 2021-06-03 |
| LifeStent 5F Vascular Stent Systems (P070014/S062) | Bard Peripheral Vascular, Inc. | 2021-06-03 |
| MitraClip NTR/XTR Delivery System (P100009/S042) | ABBOTT MEDICAL | 2021-06-03 |
| DiamondTemp Ablation System (P200028/S005) | Medtronic, Inc. | 2021-06-02 |
| Pulse Generator, Permanent, Implantable (P950037/S223) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S124) | Biotronik, Inc. | 2021-06-02 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S054) | Edwards Lifesciences, LLC | 2021-06-02 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic (P050023/S155) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S125) | Biotronik, Inc. | 2021-06-02 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S227) | Medtronic, Inc. | 2021-06-02 |
| Defibrillator, Automatic Implantable Crdioveter, with Cardiac Resynchronization (CRT-D), Defibrillator, Implantable Dual (P050023/S156) | Biotronik, Inc. | 2021-06-02 |
| Pulse Generator, Permanent, Implantable (P950037/S222) | Biotronik, Inc. | 2021-06-02 |
| Defibrillator, Implantable Dual-Chamber (P000009/S091) | Biotronik, Inc. | 2021-06-02 |
| TherOx Downstream System (P170027/S005) | Zoll Circulation, Inc. | 2021-06-01 |
| 7F Freezor Cardiac CryoablationCatheter and CCT.2 Cryoconsole System (P020045/S096) | Medtronic Cryocath, LP | 2021-06-01 |
| Epic and Epic Supra Tissue Heart Valves (P040021/S046) | ABBOTT MEDICAL | 2021-05-28 |
| DiamondTemp Ablation System (P200028/S004) | Medtronic, Inc. | 2021-05-28 |
| Endurant Stent Graft Family (P100021/S092) | Medtronic Vascular | 2021-05-28 |
| CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS (P890003/S444) | Medtronic, Inc. | 2021-05-27 |
| Promus Premier and Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S193) | Boston Scientific Corp | 2021-05-27 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S074) | Boston Scientific Corporation | 2021-05-27 |