| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems (P160043/S040) | Medtronic Vascular | 2020-12-21 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems (P110013/S105) | Medtronic Vascular | 2020-12-21 |
| HeartWare HVAD System (P100047/S169) | Medtronic | 2020-12-21 |
| Phylax AV ICD System (P000009/S089) | Biotronik, Inc. | 2020-12-18 |
| Siello S 45 leads and Solia S 45 leads (P950037/S215) | Biotronik, Inc. | 2020-12-18 |
| 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/S727) | Medtronic Cardiac Rhythm Disease Management | 2020-12-18 |
| STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD (P070008/S121) | Biotronik, Inc. | 2020-12-18 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S218) | Biotronik, Inc. | 2020-12-18 |
| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S104) | Biotronik, Inc. | 2020-12-18 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S665) | Medtronic, Inc. | 2020-12-18 |
| GORE CARDIOFORM ASD Occluder (P050006/S086) | W. L. Gore & Associates, Inc. | 2020-12-18 |
| Edwards Commander Delivery System (P200015/S007) | Edwards Lifesciences, LLC | 2020-12-18 |
| Tupos LV/ATX & Kronos LV-T CRT-D and Corox OWT Steroid LV Pacing Lead (P050023/S151) | Biotronik, Inc. | 2020-12-18 |
| Edora 8 CRT-P, Evity 8 CRT-P, and Enitra 8 CRT-P and Corox OTW, Sentus (ProMRI) OTW Drug Eluting Permanent Left Ventricu (P070008/S118) | Biotronik, Inc. | 2020-12-18 |
| Blazer Open-Irrigated Ablation Catheter and IntellaNav Open-Irrigated Ablation Catheter (P150005/S058) | Boston Scientific Corp | 2020-12-18 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S067) | St Jude Medical | 2020-12-18 |
| Ilesto 7 VR-T DX, Ilesto 7 VR-T, Ilesto 5 VR-T DX, Ilesto 5 VR-T, Iforia 7 VR-T DX, Ilesto 7 VR-T (DF4), Ilesto 5 VR-T ( (P050023/S153) | Biotronik, Inc. | 2020-12-18 |
| 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, Ev (P980016/S766) | Medtronic Cardiac Rhythm Disease Management | 2020-12-18 |
| TREO Abdominal Stent-Graft System (P190015/S008) | Bolton Medical, Inc. | 2020-12-17 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P (P010015/S460) | Medtronic, Inc. | 2020-12-17 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S031) | ABBOTT MEDICAL | 2020-12-17 |
| Epic Vascular Self-Expanding Stent System (P110035/S064) | Boston Scientific Corp | 2020-12-17 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S066) | Boston Scientific Corporation | 2020-12-17 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S040) | Boston Scientific Corp | 2020-12-17 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S040) | Boston Scientific Corp | 2020-12-17 |
| Protecta ICD, Protecta VR ICD, and Protecta XT ICD (P980016/S759) | Medtronic Cardiac Rhythm Disease Management | 2020-12-17 |
| Protecta CRT-D and Protecta XT CRT-D (P010031/S720) | Medtronic Cardiac Rhythm Disease Management | 2020-12-17 |
| AngioJet Thrombectomy Catheter (P980037/S084) | Boston Scientific Corp | 2020-12-17 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S025) | Bolton Medical, Inc. | 2020-12-17 |
| 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/S763) | Medtronic Cardiac Rhythm Disease Management | 2020-12-16 |
| Hancock II Bioprosthesis (P980043/S075) | Medtronic, Inc. | 2020-12-16 |
| Hancock Valved Conduit (P870078/S049) | Medtronic, Inc. | 2020-12-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication (P200015/S003) | Edwards Lifesciences, LLC | 2020-12-16 |
| TREO Abdominal Stent-Graft System (P190015/S007) | Bolton Medical, Inc. | 2020-12-16 |
| Mosaic Bioprosthesis (P990064/S084) | Medtronic, Inc. | 2020-12-16 |
| Wolverine Coronary Cutting Balloon (P950020/S111) | Boston Scientific Corp | 2020-12-16 |
| 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/S725) | Medtronic Cardiac Rhythm Disease Management | 2020-12-16 |
| HeartStart FR3 Defibrillator (P160028/S003) | Philips Medical Systems, Inc. | 2020-12-16 |
| Hancock Modified Orifice Valved Conduit (P790007/S064) | Medtronic Heart Valves | 2020-12-16 |
| CareLink SmartSync Device Manager Programmer (P890003/S439) | Medtronic, Inc. | 2020-12-16 |
| Assurity MRI and Endurity MRI (P140033/S060) | ABBOTT MEDICAL | 2020-12-16 |
| Micra AV TPS and Micra TPS (P150033/S089) | Medtronic, Inc. | 2020-12-16 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus ELITE Everolimus-Eluting Platinum C (P110010/S185) | Boston Scientific Corp | 2020-12-16 |
| WATCHMAN Left Atrial Appendage Closure Device with Delivery System (P130013/S039) | Boston Scientific Corp | 2020-12-16 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S004) | Boston Scientific Corporation | 2020-12-16 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System (P110019/S114) | Abbott Vascular | 2020-12-16 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S124) | Edwards Lifesciences, LLC | 2020-12-16 |
| HeartStart OnSite Defibrillator, and HeartStart Home Defibrillator (P160029/S007) | Philips Medical Systems, Inc. | 2020-12-16 |
| Tendril STS (P960013/S114) | ABBOTT MEDICAL | 2020-12-16 |
| Freestyle Bioprosthesis (P970031/S069) | Medtronic, Inc. | 2020-12-16 |
| HeartStart FRx Defibrillator (P180028/S004) | Philips Medical Systems | 2020-12-16 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System and SYNERGY XD Everolimus-Eluting Platinum Chromium C (P150003/S068) | Boston Scientific Corporation | 2020-12-16 |
| 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/S664) | Medtronic, Inc. | 2020-12-16 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S459) | Medtronic, Inc. | 2020-12-16 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit and Vitatron Crystalline Lead (P830061/S187) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve (P900061/S162) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D (P980035/S666) | Medtronic, Inc. | 2020-12-15 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI (P150005/S060) | Boston Scientific Corp | 2020-12-15 |
| CapSureFix MRI Lead (P090013/S311) | Medtronic, Inc. | 2020-12-15 |
| Transvene CS/SVS Lead (P980050/S130) | Medtronic, Inc. | 2020-12-15 |
| Attain StarFix Lead (P060039/S104) | Medtronic, Inc. | 2020-12-15 |
| 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/S723) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| 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/S762) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| CapSure VDD-2 Lead, SErvice Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead (P890003/S440) | Medtronic, Inc. | 2020-12-15 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S316) | ABBOTT MEDICAL | 2020-12-15 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead (P850089/S151) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| Anchoring Sleeve Kit and SelectSecure Lead (P030036/S127) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S153) | Medtronic, Inc. | 2020-12-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I (P980016/S765) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| Catheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL, (P930029/S068) | Medtronic, Inc. | 2020-12-15 |
| 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/S726) | Medtronic Cardiac Rhythm Disease Management | 2020-12-15 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S183) | ABBOTT MEDICAL | 2020-12-15 |
| Myocardial Pacing Lead (P120017/S025) | Medtronic, Inc. | 2020-12-15 |
| IsoFlex Optim, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960030/S072) | ABBOTT MEDICAL | 2020-12-15 |
| Tendril DX Endocardial Pacing Leads (P960013/S116) | ABBOTT MEDICAL | 2020-12-15 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S112) | Medtronic Cryocath, LP | 2020-12-15 |
| Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S137) | ABBOTT MEDICAL | 2020-12-15 |
| Micra AV TPS and Micra TPS (P150033/S091) | Medtronic, Inc. | 2020-12-15 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S388) | ABBOTT MEDICAL | 2020-12-15 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S218) | Medtronic, Inc. | 2020-12-15 |
| CapSure Epicardial Pacing Lead (P950024/S096) | Medtronic, Inc. | 2020-12-15 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S064) | ABBOTT MEDICAL | 2020-12-15 |
| Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter (P100010/S111) | Medtronic Cryocath, LP | 2020-12-15 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional), Avant VR, Avant D (P910023/S434) | ABBOTT MEDICAL | 2020-12-15 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 COnnector Port Pin Plug Kit, Lead Ad (P920015/S249) | Medtronic, Inc. | 2020-12-15 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripo (P010015/S461) | Medtronic, Inc. | 2020-12-15 |
| Supera Peripheral Stent System (P120020/S025) | Abbott Vascular (Idef Technologies Inc) | 2020-12-14 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S123) | Edwards Lifesciences, LLC | 2020-12-13 |
| EDWARDS INTUITY Elite Valve (P150036/S054) | Edwards Lifesciences, LLC | 2020-12-13 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve (P150048/S051) | Edwards Lifesciences, LLC | 2020-12-13 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S201) | Edwards Lifesciences, LLC | 2020-12-13 |
| CapSureFix Novus Lead (P930039/S222) | Medtronic, Inc. | 2020-12-11 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, and ACCOLADE MRI EL D (P150012/S105) | Boston Scientific | 2020-12-11 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCOL (N970003/S260) | Boston Scientific Corp | 2020-12-11 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S151) | Boston Scientific Corporation | 2020-12-11 |
| Blazer OI Catheter, IntellaNav OI Catheter, IntellaNav MiFi OI Catheter, IntellaTip MiFi OI Catheter (P150005/S059) | Boston Scientific Corp | 2020-12-11 |
| CapSure Sense Lead (P830061/S191) | Medtronic Cardiac Rhythm Disease Management | 2020-12-11 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P (P030005/S206) | Guidant Corp. | 2020-12-11 |
| Contak CD, Easytrak, Livian, Cognis and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibrill (P010012/S530) | Boston Scientific Corp | 2020-12-11 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S669) | Medtronic, Inc. | 2020-12-11 |