| Avalus Bioprosthesis (P170006/S018) | Medtronic, Inc. | 2020-10-22 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S452) | Medtronic, Inc. | 2020-10-22 |
| XIENCE Sierra Stent System (P110019/S112) | Abbott Vascular | 2020-10-22 |
| 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/S756) | Medtronic Cardiac Rhythm Disease Management | 2020-10-22 |
| LIFEPAK CR2 Defibrillator (P170018/S011) | Physio-Control, Inc. | 2020-10-22 |
| PG VALITUDE CRT-P and PG VISIONIST CRT-P (P030005/S203) | Guidant Corp. | 2020-10-22 |
| INVIVE, INTUA, VISIONIST, VALITUDE - CRT-P Resynchronization Devices (P030005/S200) | Guidant Corp. | 2020-10-22 |
| Micra AV TPS and Micra AV TPS (P150033/S086) | Medtronic, Inc. | 2020-10-22 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIOMRI, PROPONENT MRI, ACCOLADE MRI - Pacemaker Devices (P150012/S099) | Boston Scientific | 2020-10-22 |
| 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/S649) | Medtronic, Inc. | 2020-10-22 |
| ICD AUTOGEN CRT-D, ICD DYNAGEN CRT-D, ICD INOGEN CRT-D, ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, RESONATE CR (P010012/S524) | Boston Scientific Corp | 2020-10-22 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 supported by LATITUDE Consult (N970003/S254) | Boston Scientific Corp | 2020-10-22 |
| PG ACCOLADE MRI DR, PG ACCOLADE MRI SR, PG ESSENTIO MRI DR, PG ESSENTIO MRI SR, PG PROPONENT MRI DR, and PG PROPONENT M (P150012/S102) | Boston Scientific | 2020-10-22 |
| ICD AUTOGEN DR, ICD AUTOGEN VR, ICD DYNAGEN DR, ICD DYNAGEN VR, ICD INOGEN DR, ICD INOGEN VR, ICD ORIGEN DR, ICD ORIGEN (P960040/S455) | Boston Scientific | 2020-10-22 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT - CRT-D Resynchroniza (P010012/S522) | Boston Scientific Corp | 2020-10-22 |
| LATITUDE NXT Patient Management System, LATITUDE Wave Communicator, LATITUDE Consult Communicator, LATITUDE NXT Syst (P910077/S180) | Boston Scientific | 2020-10-22 |
| Abre Venous Self-expanding Stent System (P200026) | Medtronic Vascular, Inc. | 2020-10-21 |
| Adapta, Versa, Sensia IPG (P980035/S656) | Medtronic, Inc. | 2020-10-21 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S077) | Medtronic Vascular | 2020-10-21 |
| Endurant II/IIs Stent Graft System (P100021/S082) | Medtronic Vascular | 2020-10-21 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S010) | Biotronik AG | 2020-10-21 |
| Platinium VR and Platinium DR ICDs (Implantable Cardioverter Defibrillator) and Orchestra Plus Link (P980049/S140) | MicroPort CRM USA, Inc. | 2020-10-20 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S032) | ABBOTT MEDICAL | 2020-10-20 |
| Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator) (P060027/S104) | MicroPort CRM USA, Inc. | 2020-10-20 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S654) | Medtronic, Inc. | 2020-10-20 |
| Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers (P950029/S128) | MicroPort CRM USA, Inc. | 2020-10-20 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad (P010031/S711) | Medtronic Cardiac Rhythm Disease Management | 2020-10-19 |
| Durata, Optisure (P950022/S135) | ABBOTT MEDICAL | 2020-10-16 |
| ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers (P150012/S100) | Boston Scientific | 2020-10-16 |
| Therapy Cool Path SP Ablation Catheter (P060019/S049) | Irvine Biomedical, Inc. | 2020-10-16 |
| VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P Devices (P030005/S201) | Guidant Corp. | 2020-10-16 |
| Livewire TC Ablation Catheter, Livewire TC Cables, Safire Ablation Catheter, Safire Cables (P960016/S085) | St Jude Medical | 2020-10-16 |
| Therapy Ablation Catheter (P040014/S041) | Irvine Biomedical, Inc. | 2020-10-16 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S143) | Boston Scientific Corporation | 2020-10-16 |
| Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En (P110016/S071) | ABBOTT MEDICAL | 2020-10-16 |
| Therapy Dual 8 and Therapy 8mm Tip Thermistor Ablation Catheter (P040042/S047) | Irvine Biomedical,Inc.(Ibi) | 2020-10-16 |
| TREO Abdominal Stent-Graft System (P190015/S005) | Bolton Medical, Inc. | 2020-10-16 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S008) | Defibtech, LLC | 2020-10-16 |
| Perceval Sutureless Heart Valve (P150011/S013) | Corcym S.r.l. | 2020-10-16 |
| TactiCath Quartz Contact Force Ablation Catheter, TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S065) | St Jude Medical | 2020-10-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE Pacemakers (N970003/S255) | Boston Scientific Corp | 2020-10-16 |
| Quickflex µ, Quartet (P030054/S384) | ABBOTT MEDICAL | 2020-10-16 |
| Isoflex (P960030/S070) | ABBOTT MEDICAL | 2020-10-16 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S648) | Medtronic, Inc. | 2020-10-15 |
| Endurant, Endurant II, and Endurant IIs Stent Graft System (P100021/S084) | Medtronic Vascular | 2020-10-15 |
| Gore TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S120) | W. L. Gore & Associates, Inc. | 2020-10-15 |
| CapSure Sense Lead and Vitatron Crystalline Lead (P830061/S185) | Medtronic Cardiac Rhythm Disease Management | 2020-10-15 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead (P890003/S435) | Medtronic, Inc. | 2020-10-15 |
| SelectSecure Lead (P030036/S123) | Medtronic Cardiac Rhythm Disease Management | 2020-10-15 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, and Vitatron Crystalline Active Fixation Lead (P930039/S215) | Medtronic, Inc. | 2020-10-15 |
| Sprint Quattro Lead (P920015/S246) | Medtronic, Inc. | 2020-10-15 |
| CapSureFix MRI Lead (P090013/S309) | Medtronic, Inc. | 2020-10-15 |
| IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S052) | Medtronic, Inc. | 2020-10-14 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S006) | Medtronic Vascular, Inc. | 2020-10-14 |
| Biocor, Biocor Supra, Epic, Epic Supra (P040021/S044) | ABBOTT MEDICAL | 2020-10-14 |
| Trifecta and Trifecta Valve with Glide Technology (P100029/S043) | ABBOTT MEDICAL | 2020-10-14 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S645) | Medtronic, Inc. | 2020-10-13 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR (P980035/S646) | Medtronic, Inc. | 2020-10-13 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C (P110010/S182) | Boston Scientific Corp | 2020-10-13 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S140) | W. L. Gore & Associates, Inc. | 2020-10-13 |
| GORE VIABAHN Endoprosthesis and Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S079) | W. L. Gore & Associates, Inc. | 2020-10-13 |
| LifeVest Wearable Defibrillator (P010030/S141) | Zoll Manufacturing Corporation | 2020-10-13 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S065) | Boston Scientific Corporation | 2020-10-13 |
| Zilver Vena Venous Self-Expanding Stent (P200023) | Cook Ireland, Ltd. | 2020-10-09 |
| MetriQ Irrigation Tubing Set (P150005/S057) | Boston Scientific Corp | 2020-10-09 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- (P010015/S451) | Medtronic, Inc. | 2020-10-09 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR (P980035/S644) | Medtronic, Inc. | 2020-10-09 |
| Alto Abdominal Stent Graft System (P120006/S037) | Endologix, LLC | 2020-10-09 |
| Zenith AAA Endovascular Graft (P020018/S059) | Cook, Inc. | 2020-10-08 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S652) | Medtronic, Inc. | 2020-10-08 |
| Medtronic Attesta and Sphera MRI SureScan IPG and Pacing System (P980035/S637) | Medtronic, Inc. | 2020-10-08 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S647) | Medtronic, Inc. | 2020-10-07 |
| Covera Vascular Covered Stent (P170042/S005) | C.R. Bard, Inc. | 2020-10-07 |
| ZOLL AED Plus and ZOLL Fully Automatic AED Plus (P160015/S006) | ZOLL Medical Corporation | 2020-10-07 |
| LIFEPAK CR2 Defibrillator (P170018/S009) | Physio-Control, Inc. | 2020-10-07 |
| LOTUS Edge Valve System (P180029/S027) | Boston Scientific Corporation | 2020-10-07 |
| HeartWare Ventricular Assist System (P100047/S172) | Medtronic | 2020-10-06 |
| Adapta, Versa, Sensia IPG and Relia IPG (P980035/S643) | Medtronic, Inc. | 2020-10-06 |
| Acculink Carotid Stent System (P040012/S060) | Abbott Vascular | 2020-10-06 |
| AMPLATZER PFO Occluder (P120021/S016) | ABBOTT MEDICAL | 2020-10-06 |
| AMPLATZER Duct Occluder (P020024/S061) | ABBOTT MEDICAL | 2020-10-06 |
| AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal (Cribriform) Occluder (P000039/S071) | ABBOTT MEDICAL | 2020-10-06 |
| AMPLATZER Muscular VSD Occluder (P040040/S041) | ABBOTT MEDICAL | 2020-10-06 |
| Valiant Navion Thoracic Stent Graft System (P100040/S041) | Medtronic Vascular | 2020-10-05 |
| Resolute Onyx Coronary Stent System (P160043/S037) | Medtronic Vascular | 2020-10-05 |
| Resolute Integrity Rapid Exchange Coronary Stent System (P110013/S103) | Medtronic Vascular | 2020-10-05 |
| CoreValve Evolut R and Evolut PRO System (P130021/S080) | Medtronic, Inc. | 2020-10-05 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S051) | Medtronic, Inc. | 2020-10-05 |
| Integrity Coronary Stent System (P030009/S097) | Medtronic, Ireland | 2020-10-05 |
| Endurant II/IIs Stent Graft System (P100021/S083) | Medtronic Vascular | 2020-10-05 |
| Edwards Commander Delivery System (P140031/S120) | Edwards Lifesciences, LLC | 2020-10-05 |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S118) | W. L. Gore & Associates, Inc. | 2020-10-05 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S010) | Physio-Control, Inc. | 2020-10-04 |
| Tryton Side Branch Stent (P150039/S005) | Poseidon Medical, Inc. | 2020-10-04 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S202) | Guidant Corp. | 2020-10-01 |
| Covera Vascular Covered Stent (P170042/S008) | C.R. Bard, Inc. | 2020-10-01 |
| SmartAblate Irrigation Tubing Set (P990071/S045) | Biosense Webster, Inc. | 2020-10-01 |
| S-ICD GEN 2, S-ICD EMBLEM MRI (P110042/S146) | Boston Scientific Corporation | 2020-10-01 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S109) | Abbott Vascular, Inc. | 2020-10-01 |
| 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/S523) | Boston Scientific Corp | 2020-10-01 |