| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S178) | ABBOTT MEDICAL | 2020-06-30 |
| Microny family of Pacemakers (P970013/S082) | ABBOTT MEDICAL | 2020-06-30 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S308) | ABBOTT MEDICAL | 2020-06-30 |
| Durata And Optisure HV Passive Steroid Eluting Cardiac Leads (P950022/S134) | ABBOTT MEDICAL | 2020-06-30 |
| Thermocool Smarttouch SF (P030031/S106) | Biosense Webster, Inc. | 2020-06-26 |
| Impella 2.5, CP, and CP with SmartAssist (P140003/S065) | Abiomed, Inc. | 2020-06-26 |
| EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R/PRO/PRO+ Systems (P130021/S078) | Medtronic, Inc. | 2020-06-26 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S025) | ABBOTT MEDICAL | 2020-06-26 |
| Lutonix 035 DCB PTA Catheter Balloon (P130024/S035) | Lutonix | 2020-06-26 |
| Thermocool Smarttouch (P040036/S074) | Biosense Webster, Inc. | 2020-06-26 |
| Accent MRI Pacemaker (P140033/S054) | ABBOTT MEDICAL | 2020-06-26 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S076) | ABBOTT MEDICAL | 2020-06-26 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S003) | Medtronic Vascular, Inc. | 2020-06-25 |
| Wallstent (Tips) Endoprosthesis With Unistep Plus Delivery System (P930031/S067) | Boston Scientific Corp | 2020-06-25 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S058) | Boston Scientific Scimed, Inc. | 2020-06-25 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S106) | Medtronic Cryocath, LP | 2020-06-25 |
| Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System (P980033/S057) | Boston Scientific Corporation | 2020-06-25 |
| Cardiac Resynchronization Therapy-Defibrillator (CRT-D) (P060027/S101) | MicroPort CRM USA, Inc. | 2020-06-24 |
| Implantable Cardioverter Defibrillator (ICD) (P980049/S135) | MicroPort CRM USA, Inc. | 2020-06-24 |
| Lifeline/ReviveR, Lifeline/ReviveR Auto, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li (P160032/S007) | Defibtech, LLC | 2020-06-23 |
| Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoablation Catheters (P100010/S098) | Medtronic Cryocath, LP | 2020-06-23 |
| Carpentier-Edwards PERIMOUNT Magna Ease Aortic Heart Valve (P860057/S197) | Edwards Lifesciences, LLC | 2020-06-23 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S630) | Medtronic, Inc. | 2020-06-23 |
| Attain Stability Quard MRI Lead (P080006/S148) | Medtronic, Inc. | 2020-06-23 |
| HeartWare Ventricular Assist System (P100047/S164) | Medtronic | 2020-06-22 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S095) | Boston Scientific | 2020-06-19 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S015) | Celonova Biosciences, Inc. | 2020-06-18 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S019) | Physio-Control, Inc. | 2020-06-18 |
| Isoflex (P960030/S069) | ABBOTT MEDICAL | 2020-06-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S437) | Medtronic, Inc. | 2020-06-18 |
| Tendril MRl (P140033/S059) | ABBOTT MEDICAL | 2020-06-18 |
| Durata and Optisure High Voltage Leads (P950022/S133) | ABBOTT MEDICAL | 2020-06-18 |
| Tendril SDX, OptiSense, Tendril STS, Tendril ST (P960013/S113) | ABBOTT MEDICAL | 2020-06-18 |
| Quickflex µ, Quartet (P030054/S379) | ABBOTT MEDICAL | 2020-06-18 |
| Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S105) | Medtronic Cryocath, LP | 2020-06-18 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) (P130005/S029) | Cardiovascular Systems, Inc. | 2020-06-18 |
| Micra Transcatheter Pacing System (P150033/S070) | Medtronic, Inc. | 2020-06-17 |
| OptiSense Steroid Eluting Cardiac Lead (P960013/S112) | ABBOTT MEDICAL | 2020-06-17 |
| LifeVest Wearable Defibrillator (P010030/S139) | Zoll Manufacturing Corporation | 2020-06-17 |
| IntellaNav XP and IntellaNav MiFi XP ablation catheters (P020025/S128) | Boston Scientific | 2020-06-17 |
| LOTUS Edge Valve System (P180029/S022) | Boston Scientific Corporation | 2020-06-17 |
| Rotablator Rotational Atherectomy System, ROTAPRO Rotational Atherectomy System (P900056/S185) | Boston Scientific Corp | 2020-06-16 |
| Alto Abdominal Stent Graft System (P120006/S035) | Endologix, LLC | 2020-06-16 |
| (Pacemaker Devices) ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, ALTRUA, INSIGNIA I, NEXUS I (N970003/S251) | Boston Scientific Corp | 2020-06-15 |
| (CRT-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S197) | Guidant Corp. | 2020-06-15 |
| (Pacemaker Devices) INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S092) | Boston Scientific | 2020-06-15 |
| LATITUDE Programming System, Altrua/Insignia I/Nexus I (P910077/S177) | Boston Scientific | 2020-06-15 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S006) | Biotronik AG | 2020-06-15 |
| (ICD Devices) TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIV (P960040/S450) | Boston Scientific | 2020-06-15 |
| (CRT-D Resynchronization Devices) COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTU (P010012/S518) | Boston Scientific Corp | 2020-06-15 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S030) | ABBOTT MEDICAL | 2020-06-13 |
| WOLVERINE Coronary Cutting Balloon (P950020/S108) | Boston Scientific Corp | 2020-06-12 |
| Innova Vascular Self-Expanding Stent System (P140028/S060) | Boston Scientific Corporation | 2020-06-12 |
| LATITUDE Wave Communicators (P910077/S179) | Boston Scientific | 2020-06-12 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S032) | Boston Scientific Corp | 2020-06-12 |
| Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s (P130021/S077) | Medtronic, Inc. | 2020-06-11 |
| LOTUS Edge Valve System (P180029/S024) | Boston Scientific Corporation | 2020-06-11 |
| X Series and Propaq MD (P160022/S018) | ZOLL Medical Corporation | 2020-06-11 |
| Perceval Sutureless Heart Valve and Perceval Plus Sutureless Heart Valve (P150011/S020) | Corcym S.r.l. | 2020-06-11 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent (P110010/S179) | Boston Scientific Corp | 2020-06-09 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S062) | Boston Scientific Corporation | 2020-06-09 |
| Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P,Serena Bipolar CRT-P,Serena Quadripolar CRT-P,Solara Bi (P010015/S436) | Medtronic, Inc. | 2020-06-08 |
| Amplia MRI CRTD-D,Amplia MRI Quad CRT-D,Brava CRT-D,Brava Quad CRT-D,Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MRI C (P010031/S702) | Medtronic Cardiac Rhythm Disease Management | 2020-06-08 |
| 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,Astra X (P980035/S627) | Medtronic, Inc. | 2020-06-08 |
| 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,Evera XT D (P980016/S741) | Medtronic Cardiac Rhythm Disease Management | 2020-06-08 |
| Micra AV TPS, Micra TPS (P150033/S074) | Medtronic, Inc. | 2020-06-08 |
| AED 3 Defibrillator with Uni-Padz (P160015/S004) | ZOLL Medical Corporation | 2020-06-05 |
| TactiCath Quartz Contact Force Ablation Catheter (P130026/S058) | St Jude Medical | 2020-06-05 |
| FlexAbility and FlexAbility SE Ablation Catheter, FlexAbility Cables Sensor Enabled (P110016/S069) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder (P000039/S073) | ABBOTT MEDICAL | 2020-06-04 |
| Blazer Prime XP cardiac ablation catheters (P920047/S123) | Boston Scientific Corp | 2020-06-04 |
| Amplatzer Muscular VSD Occluder (P040040/S043) | ABBOTT MEDICAL | 2020-06-04 |
| Durata HV Leads (P950022/S132) | ABBOTT MEDICAL | 2020-06-04 |
| Amplatzer PFO Occluder (P120021/S018) | ABBOTT MEDICAL | 2020-06-04 |
| Blazer Prime HTD cardiac ablation catheter (P020025/S127) | Boston Scientific | 2020-06-04 |
| ENROUTE Transcarotid Stent System (P140026/S014) | Boston Scientific Corporation | 2020-06-04 |
| IntellaNav MiFi Open-Irrigated (OI) and IntellaTip MiFi OI ablation catheters (P150005/S056) | Boston Scientific Corp | 2020-06-04 |
| Lifeline/ReviveR, Lifeline/ReviveR AUTO, Lifeline/ReviveR VIEW, Lifeline/ReviveR VIEW AUTO, Lifeline/ReviveR ECG, and Li (P160032/S006) | Defibtech, LLC | 2020-06-04 |
| Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables (P960016/S083) | St Jude Medical | 2020-06-04 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder (P020024/S064) | ABBOTT MEDICAL | 2020-06-04 |
| TactiCath Quartz Contact Force Ablation Catheter, TactiCath Contact Force Ablation Catheter Sensor Enabled (P130026/S061) | St Jude Medical | 2020-06-04 |
| HeartWare Ventricular Assist System (P100047/S162) | Medtronic | 2020-06-03 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S076) | W. L. Gore & Associates, Inc. | 2020-06-03 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S137) | W. L. Gore & Associates, Inc. | 2020-06-03 |
| Micra AV Transcatheter Pacing System (P150033/S073) | Medtronic, Inc. | 2020-06-02 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S429) | Medtronic, Inc. | 2020-06-02 |
| CapSureFix Lead (P930039/S211) | Medtronic, Inc. | 2020-06-02 |
| Myocardial Pacing Lead (P120017/S021) | Medtronic, Inc. | 2020-06-02 |
| CapSure Sense Lead, CapSure SP Novus Lead (P830061/S181) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven (P920015/S243) | Medtronic, Inc. | 2020-06-02 |
| SelectSecure Lead (P030036/S119) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| Epicardial Patch Lead (P900061/S158) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S147) | Medtronic Cardiac Rhythm Disease Management | 2020-06-02 |
| CapSure Epicardial Pacing Lead (P950024/S092) | Medtronic, Inc. | 2020-06-02 |
| Transvene CS/SVC Lead (P980050/S126) | Medtronic, Inc. | 2020-06-02 |
| Integrity RX Coronary Stent System and Integrity OTW Coronary Stent System (P030009/S096) | Medtronic, Ireland | 2020-06-02 |
| ENROUTE Transcarotid Stent System (P140026/S015) | Boston Scientific Corporation | 2020-06-01 |
| Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S017) | Cordis US Corporation | 2020-05-29 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S008) | Bard Peripheral Vascular, Inc. | 2020-05-29 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S042) | Cordis US Corporation | 2020-05-29 |