| Resolute Integrity zotarolimus-Eluting Coronary Stent Systems (P110013/S108) | Medtronic Vascular | 2021-03-12 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System and Valiant T (P100040/S045) | Medtronic Vascular | 2021-03-12 |
| HeartWare HVAD System (P100047/S175) | Medtronic | 2021-03-11 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S159) | Medtronic, Inc. | 2021-03-11 |
| Reply SR, Reply DR (P950029/S131) | MicroPort CRM USA, Inc. | 2021-03-10 |
| HeartStart OnSite Defibrillator and HeartStart Home Defibrillator (P160029/S010) | Philips Medical Systems, Inc. | 2021-03-10 |
| HeartStart FRx Defibrillator (P180028/S007) | Philips Medical Systems | 2021-03-10 |
| Impella 2.5 System, Impella CP System and Impella CP System with SmartAssist System, Impella 5.0 System, Impella LD Syst (P140003/S074) | Abiomed, Inc. | 2021-03-10 |
| MitraClip NT Clip Delivery System, MitraClip XT Clip Delivery System, and MitraClip G4 Clip Delivery System (P100009/S039) | ABBOTT MEDICAL | 2021-03-09 |
| CardioMEMS HF System (P100045/S048) | ABBOTT MEDICAL | 2021-03-09 |
| AED Plus (P160015/S010) | ZOLL Medical Corporation | 2021-03-09 |
| Phylax AV ICD System (P000009/S086) | Biotronik, Inc. | 2021-03-08 |
| Renamic Neo Programmer (P950037/S213) | Biotronik, Inc. | 2021-03-08 |
| 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, Ev (P980016/S771) | Medtronic Cardiac Rhythm Disease Management | 2021-03-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S468) | Medtronic, Inc. | 2021-03-08 |
| Tupos LV/ATX & Kronos LV-T CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S148) | Biotronik, Inc. | 2021-03-08 |
| 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/S733) | Medtronic Cardiac Rhythm Disease Management | 2021-03-08 |
| Stratos LV CRT-P and Stratos LV-T CRT-P, Corox OTW BP Lead and Corox OTW-S BP Lead (P070008/S116) | Biotronik, Inc. | 2021-03-08 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S672) | Medtronic, Inc. | 2021-03-08 |
| DiamondTemp Ablation Catheters (P200028/S001) | Medtronic, Inc. | 2021-03-08 |
| SYNERGY, SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S070) | Boston Scientific Corporation | 2021-03-05 |
| PROMUS Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S189) | Boston Scientific Corp | 2021-03-05 |
| CapSure Epicardial Pacing Lead (P950024/S098) | Medtronic, Inc. | 2021-03-04 |
| HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead (P920015/S253) | Medtronic, Inc. | 2021-03-04 |
| CapSureFix MRI Lead (P090013/S314) | Medtronic, Inc. | 2021-03-04 |
| Myocardial Pacing Lead (P120017/S027) | Medtronic, Inc. | 2021-03-04 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S442) | Medtronic, Inc. | 2021-03-04 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S084) | W. L. Gore & Associates, Inc. | 2021-03-04 |
| SelectSecure Lead (P030036/S130) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S154) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S193) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| GORE VIATORR TIPS Endoprosthesis, GORE VIATORR TIPS Endoprosthesis with Controlled Expansion (P040027/S085) | W. L. Gore & Associates, Inc. | 2021-03-04 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, S (P010015/S466) | Medtronic, Inc. | 2021-03-04 |
| Transvene CS/SVC Lead (P980050/S132) | Medtronic, Inc. | 2021-03-04 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S223) | Medtronic, Inc. | 2021-03-04 |
| Epicardial Patch Lead (P900061/S164) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| HV Splitter/Adapter kit, Sprint Quattro Lead (P920015/S252) | Medtronic, Inc. | 2021-03-04 |
| 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/S769) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| On-X Prosthetic Heart Valve and On-X Ascending Aortic Prosthesis devices (P000037/S057) | On-X Life Technologies, Inc. | 2021-03-04 |
| 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/S731) | Medtronic Cardiac Rhythm Disease Management | 2021-03-04 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S158) | Medtronic, Inc. | 2021-03-04 |
| Attain StarFix Lead (P060039/S106) | Medtronic, Inc. | 2021-03-04 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S041) | Boston Scientific Corp | 2021-03-03 |
| 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/S671) | Medtronic, Inc. | 2021-03-03 |
| Micra AV TPS, Micra TPS (P150033/S093) | Medtronic, Inc. | 2021-03-03 |
| 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/S770) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| MetriQ Pump (P150005/S062) | Boston Scientific Corp | 2021-03-03 |
| 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/S732) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG (P980035/S675) | Medtronic, Inc. | 2021-03-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S467) | Medtronic, Inc. | 2021-03-03 |
| Epic Self Expanding Stent System (P110035/S065) | Boston Scientific Corp | 2021-03-03 |
| Arctic Front Advance and Arctic Front Advance Pro (P100010/S113) | Medtronic Cryocath, LP | 2021-03-03 |
| 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/S773) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| Amplia MRl 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/S735) | Medtronic Cardiac Rhythm Disease Management | 2021-03-03 |
| Innova Self Expanding Stent System (P140028/S067) | Boston Scientific Corporation | 2021-03-03 |
| Thermocool Smarttouch (P040036/S078) | Biosense Webster, Inc. | 2021-03-02 |
| Thermocool Smarttouch SF (P030031/S113) | Biosense Webster, Inc. | 2021-03-02 |
| VenaSeal Closure System (P140018/S023) | Medtronic Vascular, Inc. | 2021-03-02 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Thoracic Stent Graft (FreeFlo Tapers Line Extens (P100040/S044) | Medtronic Vascular | 2021-03-02 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S087) | Medtronic Vascular | 2021-03-02 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S011) | Medtronic Vascular, Inc. | 2021-03-02 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S056) | Medtronic, Inc. | 2021-03-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Proo Delivery Catheter Sys (P130021/S086) | Medtronic, Inc. | 2021-03-02 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S111) | Abbott Vascular, Inc. | 2021-02-26 |
| Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System (P130021/S085) | Medtronic, Inc. | 2021-02-26 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S002) | Defibtech, LLC | 2021-02-25 |
| PROMUS Everolimus-Eluting Coronary Stent System (P110010/S188) | Boston Scientific Corp | 2021-02-24 |
| ACUITY X4 Straight, ACUITY X4 Spiral S, ACUITY X4 Spiral L (P010012/S532) | Boston Scientific Corp | 2021-02-24 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S006) | Boston Scientific Corporation | 2021-02-24 |
| Integrity Coronary Stent System (P030009/S099) | Medtronic, Ireland | 2021-02-23 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S107) | Medtronic Vascular | 2021-02-23 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S043) | Medtronic Vascular | 2021-02-23 |
| MitraClip Clip System (P100009/S038) | ABBOTT MEDICAL | 2021-02-22 |
| Stellarex 035 OTW Drug-Coated Angiopiasty Balloon (DCB) (P160049/S011) | The Spectranetics Corp. | 2021-02-19 |
| IN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S010) | Medtronic Vascular, Inc. | 2021-02-18 |
| Micra TPS (P150033/S092) | Medtronic, Inc. | 2021-02-18 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S039) | Medtronic Vascular | 2021-02-18 |
| Orchestra/Orchestra Plus C3PR/C3PRH, Orchestra Plus Link, USB adapter for CPR3H, Smart ECG (P980049/S137) | MicroPort CRM USA, Inc. | 2021-02-18 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S016) | Berlin Heart, Inc. | 2021-02-17 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.5 with SmartAssist, and Impella 5.0/LD (P140003/S079) | Abiomed, Inc. | 2021-02-17 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S014) | Biotronik AG | 2021-02-17 |
| AngelMed Guardian System (P150009/S005) | Avertix Medical, Inc. | 2021-02-17 |
| SAPIEN 3 Transcatheter Heart Valve System (P200015/S005) | Edwards Lifesciences, LLC | 2021-02-17 |
| 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/S673) | Medtronic, Inc. | 2021-02-17 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S126) | Edwards Lifesciences, LLC | 2021-02-17 |
| Micra AV TPS, Micra TPS (P150033/S094) | Medtronic, Inc. | 2021-02-16 |
| LIFEPAK CR2 Automated External Defibrillator (P170018/S012) | Physio-Control, Inc. | 2021-02-16 |
| HeartWare HVAD System (P100047/S149) | Medtronic | 2021-02-12 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039) | Shockwave Medical, Inc. | 2021-02-12 |
| HeartStart FRx Defibrillator (P180028/S006) | Philips Medical Systems | 2021-02-12 |
| HeartStart Home Defibrillator and HeartStart OnSite Defibrillator (P160029/S009) | Philips Medical Systems, Inc. | 2021-02-12 |
| CareLink SmartSync Azure Astra Application (P980035/S670) | Medtronic, Inc. | 2021-02-12 |
| CareLink SmartSync Percepta Serena Solara Application (P010015/S464) | Medtronic, Inc. | 2021-02-12 |
| Tridyne Vascular Sealant (Tridyne VS) (P150016/S020) | Neomend, Inc. | 2021-02-11 |
| Arctic Front Cardiac CryoAblation System: Arctic Front Advance, Arctic Front Advance Pro and Freezor MAX Cardiac Cryoabl (P100010/S108) | Medtronic Cryocath, LP | 2021-02-11 |
| VICI VENOUS STENT System and VICI RDS Stent System (P180013/S006) | Boston Scientific Corporation | 2021-02-11 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S003) | Boston Scientific Corporation | 2021-02-10 |
| WATCHMAN and WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S041) | Boston Scientific Corp | 2021-02-10 |
| SelectSecure Lead (P030036/S129) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S153) | Medtronic Cardiac Rhythm Disease Management | 2021-02-09 |