| GORE TAG Thoracic Endoprosthesis product family (P040043/S114) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| BioMimics 3D Vascular Stent System (P180003/S002) | Veryan Medical, Ltd. | 2020-04-10 |
| GORE CARDIOFORM Occluder product family (P050006/S082) | W. L. Gore & Associates, Inc. | 2020-04-10 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S001) | Medtronic Vascular, Inc. | 2020-04-10 |
| VenaSeal Closure System (P140018/S019) | Medtronic Vascular, Inc. | 2020-04-10 |
| EDWARDS INTUITY Elite Valve (P150036/S048) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S105) | Edwards Lifesciences, LLC | 2020-04-10 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2020-04-10 |
| Carpentier-Edwards PERIMOUNT, Plus, Theon, RSR, Magna,Magna Ease, Mega Mitral Pericardial Aortic Bioprosthesis with Ther (P860057/S196) | Edwards Lifesciences, LLC | 2020-04-10 |
| Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve (P140031/S102) | Edwards Lifesciences, LLC | 2020-04-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S060) | Boston Scientific Corporation | 2020-04-09 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S071) | Abiomed, Inc. | 2020-04-09 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S025) | Medinol, Ltd. | 2020-04-09 |
| Impella RP (P170011/S023) | Abiomed, Inc. | 2020-04-09 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S026) | ABBOTT MEDICAL | 2020-04-09 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S031) | Medtronic Vascular | 2020-04-09 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S035) | Medinol, Ltd. | 2020-04-09 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S077) | ABBOTT MEDICAL | 2020-04-09 |
| HeartWare Ventricular Assist System (P100047/S157) | Medtronic | 2020-04-08 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S026) | W. L. Gore & Associates, Inc. | 2020-04-08 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S451) | Boston Scientific | 2020-04-07 |
| 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/S519) | Boston Scientific Corp | 2020-04-07 |
| S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S136) | Boston Scientific Corporation | 2020-04-07 |
| 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/S733) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| CapSure Sense Lead (P830061/S180) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| 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/S694) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| 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/S695) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| 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/S621) | Medtronic, Inc. | 2020-04-06 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S431) | Medtronic, Inc. | 2020-04-06 |
| 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/S734) | Medtronic Cardiac Rhythm Disease Management | 2020-04-06 |
| Micra TPS (P150033/S068) | Medtronic, Inc. | 2020-04-06 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S056) | St Jude Medical | 2020-04-06 |
| XIENCE Sierra Everolimus Eluting Coronary System (P110019/S109) | Abbott Vascular | 2020-04-06 |
| Solo Smart Heart Valve (P130011/S009) | Corcym Canada Corp | 2020-04-03 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S019) | Corcym S.r.l. | 2020-04-03 |
| Promus PREMIER and Promus ELITE (P110010/S177) | Boston Scientific Corp | 2020-04-03 |
| WOLVERINE Coronary Cutting Balloon (P950020/S107) | Boston Scientific Corp | 2020-04-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S068) | Boston Scientific Corp | 2020-04-02 |
| Endurant, Endurant II, and Endurant lls Stent Graft System (P100021/S080) | Medtronic Vascular | 2020-04-02 |
| Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRTD, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MR (P010031/S693) | Medtronic Cardiac Rhythm Disease Management | 2020-04-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI (P980016/S732) | Medtronic Cardiac Rhythm Disease Management | 2020-04-02 |
| ICD Devices: TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT and PERC (P960040/S446) | Boston Scientific | 2020-04-01 |
| CRT-D Resynchronization Devices: COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM (P010012/S514) | Boston Scientific Corp | 2020-04-01 |
| LATITUDE NXT System - LATITUDE NXT Patient Management System, LATITUDE Wave Communicator and LATITUDE NXT System Server (P910077/S176) | Boston Scientific | 2020-04-01 |
| CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S193) | Guidant Corp. | 2020-04-01 |
| HeartWare Ventricular Assist System (P100047/S155) | Medtronic | 2020-04-01 |
| Micra Transcatheter Pacing System and Micra AV TPS (P150033/S069) | Medtronic, Inc. | 2020-04-01 |
| Pacemaker Devices - INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S088) | Boston Scientific | 2020-04-01 |
| Subcutaneous ICD Devices: EMBLEM S-ICD (P110042/S133) | Boston Scientific Corporation | 2020-04-01 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S024) | Boston Scientific Corp | 2020-04-01 |
| Impella RP System (P170011/S021) | Abiomed, Inc. | 2020-04-01 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD and Impella 5.5 with SmartAssist Systems (P140003/S068) | Abiomed, Inc. | 2020-04-01 |
| Pacemaker Devices - ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported (N970003/S247) | Boston Scientific Corp | 2020-04-01 |
| Edwards SAPIEN 3 Transcatheter Heart Valves and Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S111) | Edwards Lifesciences, LLC | 2020-04-01 |
| Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P040036/S071) | Biosense Webster, Inc. | 2020-03-31 |
| Thermocool Smarttouch Bi-Directional Navigation Catheter, Thermocool Smarttouch SF Uni-Directional Navigation Catheter, (P030031/S103) | Biosense Webster, Inc. | 2020-03-31 |
| Inoue Balloon Catheter (P910054/S007) | Toray Industries (America), Inc. | 2020-03-30 |
| Impella RP System (P170011/S022) | Abiomed, Inc. | 2020-03-30 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S027) | ABBOTT MEDICAL | 2020-03-30 |
| HeartWare Ventricular Assist System (P100047/S156) | Medtronic | 2020-03-30 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S010) | Celonova Biosciences, Inc. | 2020-03-29 |
| Veryan BioMimics 3D Vascular Stent System (P180003/S001) | Veryan Medical, Ltd. | 2020-03-27 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S057) | St Jude Medical | 2020-03-27 |
| LifeVest Wearable Defibrillator (P010030/S132) | Zoll Manufacturing Corporation | 2020-03-26 |
| Reply SR and Reply DR Pacemakers (P950029/S125) | MicroPort CRM USA, Inc. | 2020-03-26 |
| Tendril SDX, OptiSense, Tendril STS, and Tendril ST (P960013/S111) | ABBOTT MEDICAL | 2020-03-26 |
| Durata, Optisure (P950022/S130) | ABBOTT MEDICAL | 2020-03-26 |
| Isoflex (P960030/S068) | ABBOTT MEDICAL | 2020-03-26 |
| Tendril MRI (P140033/S056) | ABBOTT MEDICAL | 2020-03-26 |
| Quickflex, Quartet (P030054/S377) | ABBOTT MEDICAL | 2020-03-26 |
| StarClose SE Vascular Closure System (P050007/S039) | Abbott Vascular Devices | 2020-03-25 |
| WOLVERINE Coronary Cutting Balloon (P950020/S105) | Boston Scientific Corp | 2020-03-25 |
| Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft (P990046/S057) | Medtronic Ats Medical, Inc. | 2020-03-24 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S033) | Medtronic Vascular | 2020-03-24 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S101) | Medtronic Vascular | 2020-03-24 |
| HeartWare Ventricular Assist System (P100047/S158) | Medtronic | 2020-03-20 |
| EMBLEM S-ICD System (P110042/S132) | Boston Scientific Corporation | 2020-03-20 |
| Open Pivot Heart Valves and Open Pivot Aortic Valved Graft (P990046/S056) | Medtronic Ats Medical, Inc. | 2020-03-20 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System (P130021/S073) | Medtronic, Inc. | 2020-03-20 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter (P130024/S031) | Lutonix | 2020-03-20 |
| CentriMag Circulatory Support System (P170038/S001) | Abbott | 2020-03-20 |
| MULTI-LINK 8, MULTI-LINK 8 SV/LL CORONARY STENT SYSTEMS (P020047/S072) | Abbott Vascular | 2020-03-19 |
| XIENCE PRIME, XIENCE PRIME SV/LL, XIENCE Xpedition, XIENCE Xpedition SV/LL, XIENCE Alpine, and XIENCE Sierra EVEROLIMUS (P110019/S108) | Abbott Vascular | 2020-03-19 |
| Attain Stability Quad MRI Lead (P080006/S145) | Medtronic, Inc. | 2020-03-19 |
| XIENCE V and XIENCE Nano EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (P070015/S146) | Abbott Vascular, Inc. | 2020-03-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S097) | Boston Scientific Corp | 2020-03-17 |
| VENOUS WALLSTENT (P980033/S050) | Boston Scientific Corporation | 2020-03-17 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOLAD (N970003/S250) | Boston Scientific Corp | 2020-03-17 |
| SICD Gen 2 and SICD MRI (P110042/S135) | Boston Scientific Corporation | 2020-03-17 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT- (P010012/S517) | Boston Scientific Corp | 2020-03-17 |
| INCRAFT AAA Stent Graft System (P150002/S007) | Cordis US Corporation | 2020-03-17 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D (P150012/S091) | Boston Scientific | 2020-03-17 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR (P960040/S449) | Boston Scientific | 2020-03-17 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P (P030005/S196) | Guidant Corp. | 2020-03-17 |
| Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrodes (P070008/S113) | Biotronik, Inc. | 2020-03-16 |
| Ellipse DR and Ellipse VR (P910023/S426) | ABBOTT MEDICAL | 2020-03-13 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S006) | Berlin Heart, Inc. | 2020-03-13 |
| Alto Abdominal Stent Graft System (P120006/S031) | Endologix, LLC | 2020-03-13 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S078) | Syncardia Systems, LLC | 2020-03-12 |
| samaritan Public Access Automated External Defibrillators and Accessories (P160008/S010) | Heartsine Technologies, Ltd. | 2020-03-12 |