| HeartLight System (P150026/S010) | Cardiofocus, Inc. | 2020-02-20 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S026) | Boston Scientific Corp | 2020-02-20 |
| WOLVERINE Coronary Cutting Balloon (P950020/S101) | Boston Scientific Corp | 2020-02-20 |
| Innova Vascular Self-Expanding Stent System (P140028/S054) | Boston Scientific Corporation | 2020-02-20 |
| In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S049) | Medtronic, Inc. | 2020-02-20 |
| EXCOR IKUS Driver (P160035/S008) | Berlin Heart, Inc. | 2020-02-20 |
| IntellaNav ST Temperature Ablation Catheter (P920047/S121) | Boston Scientific Corp | 2020-02-19 |
| IntellaTip MiFi XP, IntellaNav MiFi XP and IntellaNav XP Temperature Ablation Catheters (P020025/S125) | Boston Scientific | 2020-02-19 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI Open-Irrigated Ablation Catheters (P150005/S052) | Boston Scientific Corp | 2020-02-19 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist, and Impella LD Systems (P140003/S059) | Abiomed, Inc. | 2020-02-18 |
| HeartWare Ventricular Assist System (P100047/S152) | Medtronic | 2020-02-18 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S027) | Medtronic Vascular | 2020-02-14 |
| Xience Sierra Everolimus Eluting Coronary Stent System (P110019/S110) | Abbott Vascular | 2020-02-13 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S014) | Physio-Control, Inc. | 2020-02-13 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S021) | Bolton Medical, Inc. | 2020-02-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S023) | Boston Scientific Corp | 2020-02-12 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S008) | The Spectranetics Corp. | 2020-02-11 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S018) | Corcym S.r.l. | 2020-02-10 |
| Solo Smart Heart Valve (P130011/S008) | Corcym Canada Corp | 2020-02-10 |
| Blazer Prime XP and IntellaTip MiFi XP (P020025/S124) | Boston Scientific | 2020-02-07 |
| Zilver Vascular Stent (P050017/S018) | Cook Ireland, Ltd. | 2020-02-07 |
| Blazer Prime HTD (P920047/S120) | Boston Scientific Corp | 2020-02-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S022) | Boston Scientific Corp | 2020-02-06 |
| Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch (P110010/S174) | Boston Scientific Corp | 2020-02-06 |
| CardioMEMS HF System (P100045/S041) | ABBOTT MEDICAL | 2020-02-05 |
| GORE EXCLUDER AAA Endoprosthesis (P020004/S166) | W. L. Gore & Associates, Inc. | 2020-02-05 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S209) | Medtronic, Inc. | 2020-02-04 |
| Medtronic SelectSecure MRI SureScan Lead (P030036/S117) | Medtronic Cardiac Rhythm Disease Management | 2020-02-03 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S101) | Medtronic Cryocath, LP | 2020-02-03 |
| Freezor, Arctic Front Advance (AFA) CryoAblation Catheters (P020045/S093) | Medtronic Cryocath, LP | 2020-02-03 |
| Mosaic Bioprosthesis (P990064/S081) | Medtronic, Inc. | 2020-02-02 |
| Rotapro Rotational Atherectomy System (P900056/S181) | Boston Scientific Corp | 2020-01-30 |
| Automated Impella Controller (P170011/S015) | Abiomed, Inc. | 2020-01-30 |
| Automated Impella Controller (P140003/S057) | Abiomed, Inc. | 2020-01-30 |
| Drug Eluting Permanent Right Venticular/Right Atrial Pacemaker Electrodes, Stylets, Stylet, Catheter, Blind Plug, Perman (P950037/S209) | Biotronik, Inc. | 2020-01-29 |
| Gore Viatorr Tips Endoprosthesis and Gore Viatorr Tips Endoprosthesis with Controlled Expansion (P040027/S077) | W. L. Gore & Associates, Inc. | 2020-01-29 |
| Stylet Catheter, Implantable Cardioverter Defibrillator, Implantable Dual-Chamber Defibrillator, Defibrillator Automatic (P050023/S141) | Biotronik, Inc. | 2020-01-29 |
| Drug Eluting Permanent Left Ventricular Pacemaker Electrode, Pulse Generator Pacemaker Implantable with Cardiac Resynchr (P070008/S111) | Biotronik, Inc. | 2020-01-29 |
| Permanent Defibrillator Electrodes, Accessories to Permanent Pacemaker Electrode, Stylet Catheter (P980023/S097) | Biotronik, Inc. | 2020-01-29 |
| PG ESSENTIO SR/DR SL, PG PROPONENT SR/DR SL, DR EL, PG ACCOLADE SR/DR SL, DR EL, PG ALTRUA 2 SR/DR SL, DR EL (N970003/S248) | Boston Scientific Corp | 2020-01-28 |
| PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL (P030005/S194) | Guidant Corp. | 2020-01-28 |
| PG ESSENTION MRI SR/DR SL, PG ESSENTIO DR EL, PG ESSENTIO MRI DR EL, PG PROPONENT MRI SR/DR/ SL, PG PROPONENT MRI DR EL, (P150012/S089) | Boston Scientific | 2020-01-28 |
| ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1 (P010012/S515) | Boston Scientific Corp | 2020-01-28 |
| Sprint Quattro Lead (P920015/S241) | Medtronic, Inc. | 2020-01-28 |
| Tack Endovascular System (6F) (P180034/S001) | Philips Image Guided Therapy Corporation | 2020-01-28 |
| ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE (P960040/S447) | Boston Scientific | 2020-01-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S021) | ABBOTT MEDICAL | 2020-01-27 |
| IntellaNav MiFi XP amd IntellaNav XP (P020025/S123) | Boston Scientific | 2020-01-27 |
| IntellaNav OI and IntellaNav MiFi OI (P150005/S051) | Boston Scientific Corp | 2020-01-27 |
| HeartWare HVAD System (P100047/S150) | Medtronic | 2020-01-27 |
| IntellaNav ST (P920047/S119) | Boston Scientific Corp | 2020-01-27 |
| HeartMate II Left Ventricular Assist System (P060040/S073) | ABBOTT MEDICAL | 2020-01-27 |
| VenaSeal Closure System (P140018/S018) | Medtronic Vascular, Inc. | 2020-01-25 |
| AED Plus (P160015/S003) | ZOLL Medical Corporation | 2020-01-24 |
| Impella RP System (P170011/S020) | Abiomed, Inc. | 2020-01-24 |
| Astron Pulsar Stent System (P160025/S007) | Biotronik AG | 2020-01-23 |
| GORE TIGRIS Vascular Stent (P160004/S029) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S025) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S007) | Biotronik AG | 2020-01-23 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S001) | Biotronik AG | 2020-01-23 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S009) | Biotronik AG | 2020-01-23 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S074) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S135) | W. L. Gore & Associates, Inc. | 2020-01-23 |
| MANTA Vascular Closure Device (P180025/S006) | Teleflex Medical, LLC | 2020-01-23 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S076) | Syncardia Systems, LLC | 2020-01-22 |
| IMPELLA 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist System, and (P140003/S066) | Abiomed, Inc. | 2020-01-22 |
| Arctic Front Advance Pro Cryoballoon Catheter (P100010/S100) | Medtronic Cryocath, LP | 2020-01-17 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S013) | Physio-Control, Inc. | 2020-01-17 |
| SAPIEN 3 Ultra Transcatheter Heart Valve System (THV) (P140031/S105) | Edwards Lifesciences, LLC | 2020-01-16 |
| HeartLight System (P150026/S009) | Cardiofocus, Inc. | 2020-01-16 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S189) | Edwards Lifesciences, LLC | 2020-01-15 |
| EDWARDS INTUITY Elite Valve (P150036/S039) | Edwards Lifesciences, LLC | 2020-01-15 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S034) | Edwards Lifesciences, LLC | 2020-01-15 |
| Micra Transcatheter Pacing System, Micra AV Application Software (P150033/S061) | Medtronic, Inc. | 2020-01-15 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S055) | St Jude Medical | 2020-01-14 |
| SelectSecure Lead (P030036/S116) | Medtronic Cardiac Rhythm Disease Management | 2020-01-10 |
| Transvene CS/SVC Lead (P980050/S125) | Medtronic, Inc. | 2020-01-10 |
| Sprint Quattro, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S240) | Medtronic, Inc. | 2020-01-10 |
| Micra TPS (P150033/S064) | Medtronic, Inc. | 2020-01-09 |
| 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/S726) | Medtronic Cardiac Rhythm Disease Management | 2020-01-09 |
| REBEL Platinum Chromium Coronary Stent System Monorail (P130030/S065) | Boston Scientific Corp | 2020-01-09 |
| WOLVERINE Coronary Cutting Balloon Monorail (P950020/S100) | Boston Scientific Corp | 2020-01-09 |
| 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/S687) | Medtronic Cardiac Rhythm Disease Management | 2020-01-09 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S425) | Medtronic, Inc. | 2020-01-09 |
| 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, As (P980035/S612) | Medtronic, Inc. | 2020-01-09 |
| HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S008) | Heartsine Technologies, Ltd. | 2020-01-09 |
| Endurant, Endurant II and Endurant IIs Stent Graft System (P100021/S079) | Medtronic Vascular | 2020-01-09 |
| Consulta CRT-P, Syncra CRT-P and Viva CRT-P (P010015/S424) | Medtronic, Inc. | 2020-01-07 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI, Claria MRI Quad CRT-D, Compia MRI, C (P010031/S686) | Medtronic Cardiac Rhythm Disease Management | 2020-01-07 |
| Evera MRI DF-1 ICD, Evera MRI, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Protecta (P980016/S725) | Medtronic Cardiac Rhythm Disease Management | 2020-01-07 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG and Relia IPG (P980035/S611) | Medtronic, Inc. | 2020-01-07 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S424) | ABBOTT MEDICAL | 2020-01-06 |
| Assurity MRI, Endurity MRI (P140033/S052) | ABBOTT MEDICAL | 2020-01-06 |
| Promote+, Unify, Unify Quandra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S375) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity, Assurity, and Accent (P880086/S310) | ABBOTT MEDICAL | 2020-01-06 |
| Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP (P030035/S179) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity, Endurity Core, and Assurity pacemakers (P880086/S311) | ABBOTT MEDICAL | 2020-01-06 |
| Endurity MRI, and Assurity MRI (P140033/S053) | ABBOTT MEDICAL | 2020-01-06 |
| Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S164) | Boston Scientific Corp | 2020-01-03 |
| LifeVest Wearable Defibrillator (P010030/S131) | Zoll Manufacturing Corporation | 2020-01-03 |