| Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P (P030005/S192) | Guidant Corp. | 2019-12-04 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S019) | Boston Scientific Corp | 2019-12-04 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S009) | Biotronik AG | 2019-12-04 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S056) | Boston Scientific Corporation | 2019-12-04 |
| Innova Vascular Self-Expanding Stent System (P140028/S048) | Boston Scientific Corporation | 2019-12-04 |
| Biocor, Biocor Supra, Epic and Epic Supra Heart Valves (P040021/S042) | ABBOTT MEDICAL | 2019-12-04 |
| Origen CRT-D, Origen X4 CRT-D, Momentum, Momentum CRT-D, Momentum X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Dynagen CRT-D (P010012/S513) | Boston Scientific Corp | 2019-12-04 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S005) | Biotronik AG | 2019-12-04 |
| CapSureFix MRI Lead (P090013/S302) | Medtronic, Inc. | 2019-12-04 |
| CapSureFix Novus; Vitatron Crystalline Active Fixation Lead (P930039/S205) | Medtronic, Inc. | 2019-12-04 |
| Astron Pulsar Stent System and Pulsar-18 Stent System (P160025/S009) | Biotronik AG | 2019-12-04 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S011) | Biotronik AG | 2019-12-04 |
| Promus PREMIER/ Promus ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S173) | Boston Scientific Corp | 2019-12-04 |
| Sprint Quattro Lead (P920015/S237) | Medtronic, Inc. | 2019-12-04 |
| Essentio MRI SR, Essentio MRI DR, Essentio MRI EL DR, Proponent, Accolade MRI SR, Accolade MRI DR and Accolade MRI EL DR (P150012/S087) | Boston Scientific | 2019-12-04 |
| Trifecta and Trifecta GT Heart Valves (P100029/S042) | ABBOTT MEDICAL | 2019-12-04 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S177) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| CapSureFix MRI Lead (P090013/S303) | Medtronic, Inc. | 2019-12-03 |
| Attain StarFix Lead (P060039/S098) | Medtronic, Inc. | 2019-12-03 |
| Myocardial Pacing Lead (P120017/S020) | Medtronic, Inc. | 2019-12-03 |
| HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC L (P920015/S239) | Medtronic, Inc. | 2019-12-03 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S143) | Medtronic, Inc. | 2019-12-03 |
| SelectSecure Lead (P030036/S115) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S VR/DR/ICD, Evera XT DR/VR/ ICD, Mirror MRI DR/VR ICD, Primo MRI DR/VR ICD, Pr (P980016/S724) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta DR/SR (P980035/S609) | Medtronic, Inc. | 2019-12-03 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSUre SP Novus Lead and Vitatron Impulse II Lead (P850089/S145) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S422) | Medtronic, Inc. | 2019-12-03 |
| Transvene CS/SVC Lead (P980050/S124) | Medtronic, Inc. | 2019-12-03 |
| Epicardial Patch Lead (P900061/S156) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| CapSure VDD-2 Lead, CareLink SmartSync Device manager Programmer and Vitatron Brilliant S+ VDD Lead (P890003/S422) | Medtronic, Inc. | 2019-12-03 |
| Gore Viabahn VBX Balloon Expandable Endoprosthesis (P160021/S023) | W. L. Gore & Associates, Inc. | 2019-12-03 |
| Amplia MRI CRT-D, Amplia/Claria/Compia MRI QUAD CRT-D, Brava CRT-D, Brava Quad CRT-D, Compia MRI CRT-D,Consulta/Protecta (P010031/S685) | Medtronic Cardiac Rhythm Disease Management | 2019-12-03 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S207) | Medtronic, Inc. | 2019-12-03 |
| CapSure Epicardial Pacing Lead (P950024/S090) | Medtronic, Inc. | 2019-12-03 |
| Micra TPS (P150033/S063) | Medtronic, Inc. | 2019-12-03 |
| VICI VENOUS STENT System (P180013/S003) | Boston Scientific Corporation | 2019-12-02 |
| Impella 5.5 with SmartAssist (P140003/S064) | Abiomed, Inc. | 2019-11-28 |
| CapSure Sense Lead (P830061/S178) | Medtronic Cardiac Rhythm Disease Management | 2019-11-27 |
| Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL (P030005/S191) | Guidant Corp. | 2019-11-27 |
| CapSureFix MRI Lead (P090013/S304) | Medtronic, Inc. | 2019-11-27 |
| CapSureFix Novus Lead (P930039/S208) | Medtronic, Inc. | 2019-11-27 |
| Essentio SR/DR SL, Essentio DR EL, Proponent SR/DR SL, Proponent DR EL, Accolade SR/DR SL, Accolade DR EL, Altrua 2 SR/D (N970003/S245) | Boston Scientific Corp | 2019-11-27 |
| Essentio MRI SR/DR SL, Essentio MRI DR EL, Proponent MRI SR/DR SL, Proponent MRI DR EL, Accolade MRI SR/DR SL and Accola (P150012/S086) | Boston Scientific | 2019-11-27 |
| PROMUS PREMIER Everolimus-Eluting Chromium Coronary Stent System (Monorail and Over The Wire) and PROMUS ELITE Everolimu (P110010/S172) | Boston Scientific Corp | 2019-11-26 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S063) | Boston Scientific Corp | 2019-11-26 |
| Carpentier-Edwards Perimount Aortic Bioprostheses and Carpentier-Edwards Perimount Mitral Bioprostheses (P860057/S195) | Edwards Lifesciences, LLC | 2019-11-26 |
| LATITUDE Programming System (P910077/S175) | Boston Scientific | 2019-11-26 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S074) | Syncardia Systems, LLC | 2019-11-26 |
| LUTONIX 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003/S014) | Lutonix | 2019-11-26 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S057) | Boston Scientific Corporation | 2019-11-26 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S002) | Philips Medical Systems, Inc. | 2019-11-26 |
| Edwards Pericardial Aortic Bioprostheses and Edwards Inspiris Resilia Aortic Valve (P150048/S042) | Edwards Lifesciences, LLC | 2019-11-26 |
| Pulse Generator, Permanent Implantable DR-T/SR-T (P950037/S202) | Biotronik, Inc. | 2019-11-26 |
| Edwards Intuity Valves and Delivery Systems (P150036/S047) | Edwards Lifesciences, LLC | 2019-11-26 |
| Sapien 3 Transcatheter Heart Valve, Sapien 3 Ultra Transcatheter Heart Valve, Commander Delivery System, Edwards eSheath (P140031/S101) | Edwards Lifesciences, LLC | 2019-11-26 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S063) | Abiomed, Inc. | 2019-11-25 |
| Impella RP System (P170011/S019) | Abiomed, Inc. | 2019-11-25 |
| LIFEPAK 20e defibrillator/monitor (P160026/S011) | Physio-Control, Inc. | 2019-11-25 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S194) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Pericardial Aortic Bioprosthesis, Pericardial Mitral Bioprosthesis, and Inspiris Resilia Aortic Valve (P150048/S041) | Edwards Lifesciences, LLC | 2019-11-24 |
| Edwards Intuity Elite Valve System (P150036/S045) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien XT Transcatheter Heart Valve (P130009/S104) | Edwards Lifesciences, LLC | 2019-11-24 |
| Sapien 3 Transcatheter Heart Valve and Ultra Transcatheter Heart Valve (P140031/S100) | Edwards Lifesciences, LLC | 2019-11-24 |
| LOTUS Edge Valve System (P180029/S017) | Boston Scientific Corporation | 2019-11-21 |
| BioGlue Surgical Adhesive (P010003/S033) | Cryolife, Inc. | 2019-11-21 |
| Rotablator (Rotablator RotaLink Plus, RotaLink Burr)/ROTAPRO Rotational Atherectomy System (ROTAPRO Plus) (P900056/S180) | Boston Scientific Corp | 2019-11-21 |
| Micra Transcatheter Pacing System (P150033/S060) | Medtronic, Inc. | 2019-11-21 |
| Mitroflow Aortic Pericardial Heart Valve (P060038/S033) | Corcym Canada Corp | 2019-11-21 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008) | Medtronic Vascular, Inc. | 2019-11-21 |
| HeartMate 3 Left Ventricular Assist System (P160054/S022) | ABBOTT MEDICAL | 2019-11-20 |
| Micra MC1VR01 Transcatheter Pacing System (TPS) (P150033/S059) | Medtronic, Inc. | 2019-11-20 |
| HeartMate II Left Ventricular Assist System (P060040/S074) | ABBOTT MEDICAL | 2019-11-20 |
| Impella RP (P170011/S018) | Abiomed, Inc. | 2019-11-20 |
| EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syst (P110023/S028) | Medtronic Vascular, Inc. | 2019-11-20 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S062) | Abiomed, Inc. | 2019-11-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S019) | Medinol, Ltd. | 2019-11-19 |
| LifeVest Wearable Defibrillator (P010030/S128) | Zoll Manufacturing Corporation | 2019-11-19 |
| HeartSines samaritan Public Access Automated External Defibrillators and Accessories (P160008/S007) | Heartsine Technologies, Ltd. | 2019-11-19 |
| Gore Cardioform ASD Occluder (P050006/S081) | W. L. Gore & Associates, Inc. | 2019-11-19 |
| Edwards Intuity Elite Valve System (P150036/S044) | Edwards Lifesciences, LLC | 2019-11-18 |
| Edwards Inspiris Resilia Aortic Valve (P150048/S040) | Edwards Lifesciences, LLC | 2019-11-18 |
| Carpentier-Edwards Perimount Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Theon RSR Pericardial (P860057/S193) | Edwards Lifesciences, LLC | 2019-11-18 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S511) | Boston Scientific Corp | 2019-11-15 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S444) | Boston Scientific | 2019-11-15 |
| Ellipse ICD Devices (P910023/S421) | ABBOTT MEDICAL | 2019-11-14 |
| Edwards Intuity Elite Delivery System (P150036/S046) | Edwards Lifesciences, LLC | 2019-11-14 |
| AngioJet Rheolytic Thrombectomy System (P980037/S074) | Boston Scientific Corp | 2019-11-13 |
| EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve (P130021/S067) | Medtronic, Inc. | 2019-11-13 |
| Lotus Edge Valve System (P180029/S016) | Boston Scientific Corporation | 2019-11-12 |
| CareLink SmartSync Device Manager and MyCareLink Patient Monitor (P890003/S420) | Medtronic, Inc. | 2019-11-12 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S002) | Biotronik AG | 2019-11-12 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S033) | Cook Ireland, Ltd. | 2019-11-12 |
| HeartLight Endoscopic Ablation System (P150026/S007) | Cardiofocus, Inc. | 2019-11-08 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S022) | Medinol, Ltd. | 2019-11-07 |
| Rotablator Rotational Angioplasty System Guidewire with wireClip Torquer (P900056/S179) | Boston Scientific Corp | 2019-11-07 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S013) | Celonova Biosciences, Inc. | 2019-11-07 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S122) | Boston Scientific | 2019-11-07 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S034) | Medinol, Ltd. | 2019-11-07 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S118) | Boston Scientific Corp | 2019-11-07 |
| Edwards Intuity Elite Valve System (P150036/S042) | Edwards Lifesciences, LLC | 2019-11-07 |