| Eluvia Drug-Eluting Vascular Stent System (P180011/S037) | Boston Scientific Corp | 2020-08-28 |
| Epic Vascular Self-Expanding Stent System (P110035/S062) | Boston Scientific Corp | 2020-08-28 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S021) | Abbott Vascular, Inc. | 2020-08-28 |
| CentriMag Circulatory Support System (P170038/S005) | Abbott | 2020-08-28 |
| Micra AV TPS and Micra TPS (P150033/S084) | Medtronic, Inc. | 2020-08-27 |
| LIFEPAK CR2 Defibrillator (P170018/S007) | Physio-Control, Inc. | 2020-08-27 |
| ImageReady MR Conditional Pacing System and INGEVITY Pace/Sense Lead (P150012/S096) | Boston Scientific | 2020-08-26 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S064) | St Jude Medical | 2020-08-25 |
| MyCareLink Smart Monitor System (P890003/S431) | Medtronic, Inc. | 2020-08-25 |
| ZOLL X Series, Propaq MD, and X Series Advanced (P160022/S013) | ZOLL Medical Corporation | 2020-08-25 |
| 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, Cobalt (P010031/S712) | Medtronic Cardiac Rhythm Disease Management | 2020-08-24 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S446) | Medtronic, Inc. | 2020-08-24 |
| Micra AV TPS and Micra TPS (P150033/S083) | Medtronic, Inc. | 2020-08-24 |
| 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, Eve (P980016/S751) | Medtronic Cardiac Rhythm Disease Management | 2020-08-24 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S636) | Medtronic, Inc. | 2020-08-24 |
| HeartStart FRx Defibrillator (P180028/S003) | Philips Medical Systems | 2020-08-22 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S006) | Philips Medical Systems, Inc. | 2020-08-22 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S008) | Biotronik AG | 2020-08-20 |
| LOTUS Edge Valve System (P180029/S025) | Boston Scientific Corporation | 2020-08-20 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S181) | Boston Scientific Corp | 2020-08-20 |
| Venovo Venous Stent System (P180037/S001) | Bard Peripheral Vascular, Inc. | 2020-08-20 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S011) | Biotronik AG | 2020-08-20 |
| Covera Vascular Covered Stent (P170042/S006) | C.R. Bard, Inc. | 2020-08-20 |
| TREO Abdominal Stent-Graft System (P190015/S002) | Bolton Medical, Inc. | 2020-08-20 |
| REBEL Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P130030/S070) | Boston Scientific Corp | 2020-08-20 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P150003/S064) | Boston Scientific Corporation | 2020-08-20 |
| Avalus Bioprosthesis (P170006/S017) | Medtronic, Inc. | 2020-08-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S028) | Medinol, Ltd. | 2020-08-20 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S030) | Medtronic Vascular, Inc. | 2020-08-18 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S030) | Medtronic Vascular, Inc. | 2020-08-18 |
| LOTUS Edge Valve System (P180029/S020) | Boston Scientific Corporation | 2020-08-17 |
| Express SD Renal Premounted Stent System (P060006/S101) | Boston Scientific Corp | 2020-08-17 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System (P130021/S076) | Medtronic, Inc. | 2020-08-17 |
| Coseal Surgical Sealant, Coseal Spray Set, Coseal Replacement Applicator, Coseal Extended Applicator (P030039/S024) | Baxter Bio Science | 2020-08-14 |
| CardioMEMS HS System (P100045/S045) | ABBOTT MEDICAL | 2020-08-14 |
| Synergy Ablation System (P100046/S012) | AtriCure, Inc. | 2020-08-14 |
| BioMimics 3D Vascular Stent System (P180003/S003) | Veryan Medical, Ltd. | 2020-08-13 |
| Arctic Front Cryocatheter System (P100010/S107) | Medtronic Cryocath, LP | 2020-08-13 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S108) | Abbott Vascular, Inc. | 2020-08-12 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S439) | Medtronic, Inc. | 2020-08-12 |
| Micra TPS and Micra AV TPS (P150033/S081) | Medtronic, Inc. | 2020-08-11 |
| Platinium VR and Platinium DR ICDs (P980049/S138) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Reply SR and Reply DR Pacemakers (P950029/S126) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Synergy Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail and Over-The-Wire) (P150003/S058) | Boston Scientific Corporation | 2020-08-10 |
| AngioJet Rheolytic Thrombectomy Catheter (P980037/S081) | Boston Scientific Corp | 2020-08-10 |
| Platinium CRT-D and Platinium 4LV CRT-D (P060027/S103) | MicroPort CRM USA, Inc. | 2020-08-10 |
| Cardinal Health Multifunctional Defibrillation Electrode (P190007) | Cardinalhealth | 2020-08-07 |
| Myocardial Pacing Lead (P120017/S023) | Medtronic, Inc. | 2020-08-06 |
| PRO-Kinetic Energy Stent System (P160003/S010) | Biotronik AG | 2020-08-06 |
| Attain Bipolar OTW Lead and Attain OTW LV Lead (P010015/S444) | Medtronic, Inc. | 2020-08-06 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S122) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S433) | Medtronic, Inc. | 2020-08-06 |
| CapSure Epicardial Pacing Lead (P950024/S094) | Medtronic, Inc. | 2020-08-06 |
| EMBLEM S-ICD Pulse Generator (P110042/S140) | Boston Scientific Corporation | 2020-08-06 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead (P850089/S149) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| GORE CARDIOFORM ASD Occluder (P050006/S084) | W. L. Gore & Associates, Inc. | 2020-08-06 |
| Epicardial Patch Lead (P900061/S160) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead (P080006/S150) | Medtronic, Inc. | 2020-08-06 |
| Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT (P910023/S431) | ABBOTT MEDICAL | 2020-08-06 |
| CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead (P830061/S184) | Medtronic Cardiac Rhythm Disease Management | 2020-08-06 |
| HeartWare HVAD System (P100047/S151) | Medtronic | 2020-08-06 |
| Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT (P030054/S383) | ABBOTT MEDICAL | 2020-08-06 |
| CapSureFix MRI Lead (P090013/S308) | Medtronic, Inc. | 2020-08-06 |
| CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S214) | Medtronic, Inc. | 2020-08-06 |
| Y Adaptor/Extender Kit, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Su (P920015/S245) | Medtronic, Inc. | 2020-08-06 |
| Transvene CS/SVC Lead (P980050/S128) | Medtronic, Inc. | 2020-08-06 |
| Attain StarFix Lead (P060039/S101) | Medtronic, Inc. | 2020-08-06 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S633) | Medtronic, Inc. | 2020-08-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S117) | W. L. Gore & Associates, Inc. | 2020-08-05 |
| AFX Endovascular AAA System (P040002/S066) | Endologix, LLC | 2020-08-05 |
| Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG (P980035/S634) | Medtronic, Inc. | 2020-08-04 |
| Impella RP System (P170011/S025) | Abiomed, Inc. | 2020-08-04 |
| CardioMEMS HF System (P100045/S043) | ABBOTT MEDICAL | 2020-08-04 |
| LifeVest Wearable Defibrillator (P010030/S138) | Zoll Manufacturing Corporation | 2020-08-04 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, and Impella 5.5 with SmartAssist (P140003/S072) | Abiomed, Inc. | 2020-08-04 |
| Micra AV TPS, Micra TPS (P150033/S079) | Medtronic, Inc. | 2020-08-04 |
| EverFlex Self-expanding Peripheral Stent System (SFA/PPA) and EverFlex Self-expanding Peripheral Stent System (iliac) (P110023/S029) | Medtronic Vascular, Inc. | 2020-08-04 |
| Protege GPS Self-expanding Peripheral Stent System (P060001/S029) | Medtronic Vascular, Inc. | 2020-08-04 |
| 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, Eve (P980016/S749) | Medtronic Cardiac Rhythm Disease Management | 2020-08-04 |
| 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, Cobalt (P010031/S709) | Medtronic Cardiac Rhythm Disease Management | 2020-08-04 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S443) | Medtronic, Inc. | 2020-08-04 |
| 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, Eve (P980016/S750) | Medtronic Cardiac Rhythm Disease Management | 2020-08-03 |
| ORIGEN, INOGEN, DYNAGEN MINI ICD VR/DR, ORIGEN, MOMENTUM, INOGEN, DYNAGEN, VIGILANT, RESONATE EL ICD VR/DR, ICD AUTOGEN, (P960040/S452) | Boston Scientific | 2020-08-03 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S635) | Medtronic, Inc. | 2020-08-03 |
| SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM (P110042/S141) | Boston Scientific Corporation | 2020-08-03 |
| HeartStart Home Defibrillator and HeartStart Onsite Defibrillator (P160029/S005) | Philips Medical Systems, Inc. | 2020-08-03 |
| CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S198) | Guidant Corp. | 2020-08-03 |
| Micra AV TPS, Micra TPS (P150033/S080) | Medtronic, Inc. | 2020-08-03 |
| HeartStart FR3 Defibrillator (P160028/S001) | Philips Medical Systems, Inc. | 2020-08-03 |
| Micra AV TPS, Micra TPS (P150033/S082) | Medtronic, Inc. | 2020-08-03 |
| Consulta CRT-P, Syncra CRT-P, Viva CRT-P (P010015/S445) | Medtronic, Inc. | 2020-08-03 |
| HeartStart FRx Defibrillator (P180028/S002) | Philips Medical Systems | 2020-08-03 |
| IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD (P150012/S097) | Boston Scientific | 2020-08-03 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S521) | Boston Scientific Corp | 2020-08-03 |
| PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE (N970003/S252) | Boston Scientific Corp | 2020-08-03 |
| 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, Cobalt (P010031/S710) | Medtronic Cardiac Rhythm Disease Management | 2020-08-03 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S175) | W. L. Gore & Associates, Inc. | 2020-07-31 |
| TREO Abdominal Stent-Graft System (P190015/S001) | Bolton Medical, Inc. | 2020-07-31 |
| GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S116) | W. L. Gore & Associates, Inc. | 2020-07-31 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S036) | Cook Ireland, Ltd. | 2020-07-31 |