| XIENCE V Everolimus Eluting Coronary Stent System, XIENCE nano Everolimus Eluting Coronary Stent System (P070015/S147) | Abbott Vascular, Inc. | 2020-03-12 |
| XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE (P110019/S111) | Abbott Vascular | 2020-03-12 |
| TherOx Downstream System (P170027/S002) | Zoll Circulation, Inc. | 2020-03-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S110) | Edwards Lifesciences, LLC | 2020-03-11 |
| EDWARDS INTUITY Elite Valve System (P150036/S050) | Edwards Lifesciences, LLC | 2020-03-11 |
| LOTUS Edge Valve System (P180029/S021) | Boston Scientific Corporation | 2020-03-11 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix Tissue Process, Carpentier-Edward (P860057/S199) | Edwards Lifesciences, LLC | 2020-03-11 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, and Rivacor 5 VR-T (P050023/S143) | Biotronik, Inc. | 2020-03-10 |
| Pulse Generator, Permanent, Implantable (P950037/S206) | Biotronik, Inc. | 2020-03-10 |
| Pulse Generator, Pacemaker, Implantable with cardiac Resynchronization (CRT-D) (P070008/S109) | Biotronik, Inc. | 2020-03-10 |
| Implantable Cardioverter Defibrillator (Non-CRT); Defibrillator, Implantable, Dual-Chamber and Defibrillator, automatic (P050023/S137) | Biotronik, Inc. | 2020-03-10 |
| Sapien 3 Ultra Transcatheter Heart Valve with the Commander Delivery System (P140031/S104) | Edwards Lifesciences, LLC | 2020-03-10 |
| Micra TPS (P150033/S066) | Medtronic, Inc. | 2020-03-06 |
| Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S102) | MicroPort CRM USA, Inc. | 2020-03-06 |
| 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/S615) | Medtronic, Inc. | 2020-03-06 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S729) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| Attain StarFix Lead (P060039/S099) | Medtronic, Inc. | 2020-03-06 |
| ACE Header, Epicardial Patch Lead (P900061/S157) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| Attain Ability Lead, Attain Stability Quad MRI Lead (P080006/S146) | Medtronic, Inc. | 2020-03-06 |
| CapSure Epicardial Pacing Lead (P950024/S091) | Medtronic, Inc. | 2020-03-06 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S179) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| CapSureFix MRI Lead (P090013/S305) | Medtronic, Inc. | 2020-03-06 |
| SelectSecure Lead (P030036/S118) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| CapSureFix Lead, CapSureFix Novus Lead (P930039/S210) | Medtronic, Inc. | 2020-03-06 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S427) | Medtronic, Inc. | 2020-03-06 |
| Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) (P980049/S136) | MicroPort CRM USA, Inc. | 2020-03-06 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+VDD Lead (P890003/S426) | Medtronic, Inc. | 2020-03-06 |
| Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Transvene CS/SVC Lead (P920015/S242) | Medtronic, Inc. | 2020-03-06 |
| 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, Compia (P010031/S690) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| Reply SR and Reply DR Pacemakers (P950029/S124) | MicroPort CRM USA, Inc. | 2020-03-06 |
| Vitatron Impulse II Lead (P850089/S146) | Medtronic Cardiac Rhythm Disease Management | 2020-03-06 |
| PG ADVANTIO DR, PG INGENIO DR, PG VITALIO DR, PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOL (N970003/S249) | Boston Scientific Corp | 2020-03-05 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P, and INTUA CRT-P (P030005/S195) | Guidant Corp. | 2020-03-05 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG (P980035/S620) | Medtronic, Inc. | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S103) | Boston Scientific Corp | 2020-03-05 |
| EDWARDS INTUITY Elite Aortic Valve (P150036/S049) | Edwards Lifesciences, LLC | 2020-03-05 |
| Wolverine Coronary Cutting Balloon (P950020/S104) | Boston Scientific Corp | 2020-03-05 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE (P860057/S198) | Edwards Lifesciences, LLC | 2020-03-05 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S448) | Boston Scientific | 2020-03-05 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards pericardial Mitral Bioprosthesis and Edwards INSPIRIS RESILIA Aortic V (P150048/S044) | Edwards Lifesciences, LLC | 2020-03-05 |
| Artic Front Advance Pro Cardiac Cryoablation Catheters (P100010/S102) | Medtronic Cryocath, LP | 2020-03-05 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S516) | Boston Scientific Corp | 2020-03-05 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S070) | Syncardia Systems, LLC | 2020-03-05 |
| S-ICD GEN and S-ICD EMBLEM MRI (P110042/S134) | Boston Scientific Corporation | 2020-03-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S109) | Edwards Lifesciences, LLC | 2020-03-05 |
| Sapien 3 Transcatheter Heart Valve and Accessories (P140031/S108) | Edwards Lifesciences, LLC | 2020-03-05 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, and PG ACCOLADE MR (P150012/S090) | Boston Scientific | 2020-03-05 |
| Therapy Dual 8 Ablation Catheter and Therapy 8mm Thermistor Ablation Catheter (P040042/S044) | Irvine Biomedical,Inc.(Ibi) | 2020-03-04 |
| Therapy Cool Path Ablation Catheter (P060019/S046) | Irvine Biomedical, Inc. | 2020-03-04 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S136) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Therapy Cool Path Duo Ablation Catheter (P110016/S066) | ABBOTT MEDICAL | 2020-03-04 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S075) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Therapy Ablation Catheter, Therapy 4mm Thermistor Ablation Catheter and Therapy Bi-Directional Ablation Catheter (P040014/S038) | Irvine Biomedical, Inc. | 2020-03-04 |
| GORE VIATORR TIPS Endoprosthesis and GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S078) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Gore Excluder AAA Endoprosthesis (P020004/S173) | W. L. Gore & Associates, Inc. | 2020-03-04 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera (P980035/S617) | Medtronic, Inc. | 2020-03-03 |
| HeartWare Ventricular Assist System (P100047/S153) | Medtronic | 2020-03-03 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S066) | Boston Scientific Corp | 2020-03-02 |
| PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System, PROMUS Premier Everolimus-Eluting Platinum Chro (P110010/S175) | Boston Scientific Corp | 2020-03-02 |
| 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/S614) | Medtronic, Inc. | 2020-03-02 |
| Freezor Cardiac Cryoablation Catheter (P020045/S092) | Medtronic Cryocath, LP | 2020-03-02 |
| 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, Compia (P010031/S689) | Medtronic Cardiac Rhythm Disease Management | 2020-03-02 |
| Express SD Premounted Renal Stent System (P060006/S099) | Boston Scientific Corp | 2020-03-02 |
| Express LD Premounted Iliac Stent System (P090003/S049) | Boston Scientific Corporation | 2020-03-02 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S426) | Medtronic, Inc. | 2020-03-02 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P130024/S033) | Lutonix | 2020-03-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera VR ICD, Intrinsic 30 ICD, Marq (P980016/S728) | Medtronic Cardiac Rhythm Disease Management | 2020-03-02 |
| Synergyst II Pulse Generator (P890003/S425) | Medtronic, Inc. | 2020-03-02 |
| Micra TPS (P150033/S065) | Medtronic, Inc. | 2020-03-02 |
| Powerheart G3 Pro Automated External Defibrillator (P160034/S002) | ZOLL Medical Corporation | 2020-03-01 |
| Fortify, Fortify Assura, and Ellipse (P910023/S425) | ABBOTT MEDICAL | 2020-02-28 |
| Impella CP with SmartAssist (P140003/S069) | Abiomed, Inc. | 2020-02-28 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S312) | ABBOTT MEDICAL | 2020-02-28 |
| GORE VIATORR TIPSEndoprosthesis product family (P040027/S074) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| Medtronic CoreValve Evolut R, Medtronic CoreValve Evolut PRO, and Medtronic Evolut PRO+ transcatheter aortic valves (TAV (P130021/S071) | Medtronic, Inc. | 2020-02-28 |
| OPTIMIZER Smart IPG (P180036/S004) | Impulse Dynamics (Usa), Inc. | 2020-02-28 |
| GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P130006/S073) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S024) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| GORE VIABAHN Endoprosthesis product family abd GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface product family (P040037/S134) | W. L. Gore & Associates, Inc. | 2020-02-28 |
| Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI (P140033/S055) | ABBOTT MEDICAL | 2020-02-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet (P030054/S376) | ABBOTT MEDICAL | 2020-02-28 |
| AED 3 defibrillator (P160015/S001) | ZOLL Medical Corporation | 2020-02-28 |
| Microny (P970013/S083) | ABBOTT MEDICAL | 2020-02-28 |
| Allure, Allure Quadra, and Quadra Allure MP (P030035/S180) | ABBOTT MEDICAL | 2020-02-28 |
| WATCHMAN Left Atrial Appendage Closure Device and Delivery System, WATCHMAN Access System (P130013/S036) | Boston Scientific Corp | 2020-02-27 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S027) | Boston Scientific Corp | 2020-02-27 |
| Navistar DS Electrophysiology Catheter (P010068/S058) | Biosense Webster, Inc. | 2020-02-26 |
| Navistar Electrophysiology Catheter (P990025/S058) | Biosense Webster, Inc. | 2020-02-26 |
| MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S037) | ABBOTT MEDICAL | 2020-02-26 |
| Celsius Electrophysiology Catheter, Deflectable Tip Electrophysiology Catheter, EZ Steer Bi-Directional Electrophysiolog (P950005/S073) | Biosense Webster, Inc. | 2020-02-26 |
| EZ Steer Thermocool Navigation, EZ Steer Thermocool Bi-Directional Catheter, Thermocool SF Nav Bi-Directional Catheter, (P030031/S101) | Biosense Webster, Inc. | 2020-02-26 |
| Thermocool Smart Touch Bi-Directional and Thermocool Smart Touch Electrophysiology (P040036/S069) | Biosense Webster, Inc. | 2020-02-26 |
| WOLVERINE Coronary Cutting Balloon (Over-The-Wire and Monorail) (P950020/S102) | Boston Scientific Corp | 2020-02-24 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S103) | Medtronic Cryocath, LP | 2020-02-24 |
| Durata and Optisure (P950022/S129) | ABBOTT MEDICAL | 2020-02-24 |
| Diamondback 360 Coronary Orbital Atherectomy System (OAS) (P130005/S028) | Cardiovascular Systems, Inc. | 2020-02-24 |
| LIFEPAK 15 monitor/defibrillator (P160026/S012) | Physio-Control, Inc. | 2020-02-21 |
| Epic Vascular Self-Expanding Stent System (P110035/S055) | Boston Scientific Corp | 2020-02-20 |
| In.Pact AV Paclitaxel-Coated PTA Balloon Catheter (P190008/S002) | Medtronic Vascular, Inc. | 2020-02-20 |