| AngioJet Rheolythic Thrombectomy Catheter System (P980037/S088) | Boston Scientific Corp | 2022-05-06 |
| ELUVIA Drug-Eluting Vascular Stent System (P180011/S049) | Boston Scientific Corp | 2022-05-06 |
| Epic Vascular Self-Expanding Stent System (P110035/S067) | Boston Scientific Corp | 2022-05-06 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S127) | Medtronic Cryocath, LP | 2022-05-06 |
| WATCHMAN FLX Left Atrial Appendage Closure System (P130013/S047) | Boston Scientific Corp | 2022-05-06 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S120) | Abbott Vascular | 2022-05-06 |
| SYNERGY Drug Eluting Coronary Stent System (P150003/S085) | Boston Scientific Corporation | 2022-05-06 |
| Philips Laser System (P910001/S115) | Spectranetics Corp. | 2022-05-05 |
| Barostim NEO Generator, Barostim NEO2 Generator, Barostim Carotid Sinus Lead, Programmer System, Carotid Sinus Lead Repa (P180050/S003) | Cvrx, Inc. | 2022-05-05 |
| Aveir VR Leadless System: Aveir Leadless Pacemaker (Right Ventricular), Aveir Delivery System Catheter, Aveir Link M (P150035/S001) | ABBOTT MEDICAL | 2022-05-04 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S782) | Medtronic Cardiac Rhythm Disease Management | 2022-05-03 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S497) | Medtronic, Inc. | 2022-05-03 |
| 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/S714) | Medtronic, Inc. | 2022-05-03 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S815) | Medtronic Cardiac Rhythm Disease Management | 2022-05-03 |
| WOLVERINE Coronary Cutting Balloon (P950020/S122) | Boston Scientific Corp | 2022-05-03 |
| ENROUTE Transcarotid Stent System (P140026/S019) | Boston Scientific Corporation | 2022-05-03 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S171) | Medtronic, Inc. | 2022-05-03 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S268) | Medtronic, Inc. | 2022-05-03 |
| Micra AV TPS, Micra TPS (P150033/S138) | Medtronic, Inc. | 2022-05-03 |
| DiamondTemp Ablation System (P200028/S009) | Medtronic, Inc. | 2022-05-02 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol (P130021/S109) | Medtronic, Inc. | 2022-04-29 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S194) | Boston Scientific Corp | 2022-04-29 |
| ENROUTE Transcarotid Stent System (P140026/S016) | Boston Scientific Corporation | 2022-04-28 |
| Patient Connector (P890003/S453) | Medtronic, Inc. | 2022-04-28 |
| Rotablator Rotational Angioplasty System, ROTAPRO Rotational Artherectomy System, ROTAWIRE Drive (P900056/S199) | Boston Scientific Corp | 2022-04-28 |
| Cordis PRECISE Nitinol Stent System (P030047/S044) | Cordis US Corporation | 2022-04-27 |
| TactiSys Quartz Equipment (P130026/S078) | St Jude Medical | 2022-04-27 |
| OCS Heart System (P180051/S001) | TransMedics, Inc. | 2022-04-27 |
| Micra AV TPS, Micra TPS (P150033/S137) | Medtronic, Inc. | 2022-04-26 |
| Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesi (P150048/S064) | Edwards Lifesciences, LLC | 2022-04-26 |
| Epic Plus Tissue Heart Valves (P040021/S050) | ABBOTT MEDICAL | 2022-04-26 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S496) | Medtronic, Inc. | 2022-04-26 |
| Barostim System (P180050/S005) | Cvrx, Inc. | 2022-04-26 |
| 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/S814) | Medtronic Cardiac Rhythm Disease Management | 2022-04-26 |
| 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/S713) | Medtronic, Inc. | 2022-04-26 |
| 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/S781) | Medtronic Cardiac Rhythm Disease Management | 2022-04-26 |
| MYNX Vascular Closure Device (P040044/S091) | Cordis US Corporation | 2022-04-25 |
| Venovo Venous Stent System (P180037/S009) | Bard Peripheral Vascular, Inc. | 2022-04-22 |
| 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/S812) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| 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/S712) | Medtronic, Inc. | 2022-04-21 |
| CapSure Epicardial Pacing Lead (P950024/S103) | Medtronic, Inc. | 2022-04-21 |
| Micra AV TPS, Micra TPS (P150033/S136) | Medtronic, Inc. | 2022-04-21 |
| Attain StarFix Lead (P060039/S110) | Medtronic, Inc. | 2022-04-21 |
| Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad (P920015/S267) | Medtronic, Inc. | 2022-04-21 |
| CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead (P890003/S452) | Medtronic, Inc. | 2022-04-21 |
| Anchoring Sleeve Kit, SelectSecure Lead (P030036/S137) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S206) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S161) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena (P010015/S495) | Medtronic, Inc. | 2022-04-21 |
| End Cap, Epicardial Patch Lead, Upsizing Sleeve (P900061/S168) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| Transvene CS/SVC Lead (P980050/S137) | Medtronic, Inc. | 2022-04-21 |
| CapSureFix MRI Lead (P090013/S320) | Medtronic, Inc. | 2022-04-21 |
| 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/S780) | Medtronic Cardiac Rhythm Disease Management | 2022-04-21 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S241) | Medtronic, Inc. | 2022-04-21 |
| Myocardial Pacing Lead (P120017/S030) | Medtronic, Inc. | 2022-04-21 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S170) | Medtronic, Inc. | 2022-04-21 |
| Edwards INTUITY ELITE Delivery System (P150036/S062) | Edwards Lifesciences, LLC | 2022-04-20 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S059) | Medtronic Vascular | 2022-04-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S039) | Medinol, Ltd. | 2022-04-20 |
| Portico Transcatheter Aortic Heart Valve (P190023/S007) | ABBOTT MEDICAL | 2022-04-20 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S041) | Medinol, Ltd. | 2022-04-19 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System RX and OTW (P110013/S116) | Medtronic Vascular | 2022-04-19 |
| Impella RP System, Impella RP with SmartAssist System (P170011/S035) | Abiomed, Inc. | 2022-04-19 |
| Integrity Rapid Exchange Coronary Stent System, Integrity Over The Wire Coronary Stent System (P030009/S107) | Medtronic, Ireland | 2022-04-19 |
| Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella (P140003/S088) | Abiomed, Inc. | 2022-04-19 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System, Valiant Navion Thoracic Stent Graft System (P100040/S051) | Medtronic Vascular | 2022-04-19 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S113) | Medtronic, Inc. | 2022-04-19 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S103) | Medtronic Vascular | 2022-04-19 |
| Thoraflex Hybrid (P210006) | Vascutek, Ltd. | 2022-04-19 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S779) | Medtronic Cardiac Rhythm Disease Management | 2022-04-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S811) | Medtronic Cardiac Rhythm Disease Management | 2022-04-15 |
| Trifecta and Trifecta Valve with Glide Technology (Trifecta GT) valves (P100029/S046) | ABBOTT MEDICAL | 2022-04-14 |
| Epic, Epic Supra and Epic Plus Tissue Heart Valves, Biocor and Biocor Supra Tissue Heart Valves (P040021/S049) | ABBOTT MEDICAL | 2022-04-14 |
| BioFreedom Drug Coated Coronary Stent System (P190020) | Biosensors International USA, Inc. | 2022-04-14 |
| Barostim System (P180050/S002) | Cvrx, Inc. | 2022-04-14 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S005) | Cook Medical Incorporated | 2022-04-14 |
| Zenith Dissection Endovascular System (P180001/S004) | William Cook Europe Aps | 2022-04-14 |
| EluNIR TM Ridaforolimus Eluting Coronary Stent System (P170008/S040) | Medinol, Ltd. | 2022-04-14 |
| Tachy DF4 header core (P960040/S477) | Boston Scientific | 2022-04-13 |
| Tachy DF4 header core (P010012/S553) | Boston Scientific Corp | 2022-04-13 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella LD, Impella 5.5 with SmartAssist (P140003/S097) | Abiomed, Inc. | 2022-04-12 |
| Barostim System (P180050/S004) | Cvrx, Inc. | 2022-04-12 |
| CardioMEMS HF System (P100045/S059) | ABBOTT MEDICAL | 2022-04-12 |
| Impella RP, Impella RP with SmartAssist (P170011/S038) | Abiomed, Inc. | 2022-04-12 |
| PSW 2201.U/1 and NEO 2201.U/1 (P000009/S097) | Biotronik, Inc. | 2022-04-11 |
| CardioMEMS PA Sensor and Delivery System (P100045/S062) | ABBOTT MEDICAL | 2022-04-11 |
| Stellarex 0.035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S017) | The Spectranetics Corp. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P070008/S136) | Biotronik, Inc. | 2022-04-11 |
| HeartMate 3 Left Ventricular Assist System (P160054/S047) | ABBOTT MEDICAL | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P980023/S111) | Biotronik, Inc. | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P050023/S166) | Biotronik, Inc. | 2022-04-11 |
| HeartMate II Left Ventricular Assist System (P060040/S085) | ABBOTT MEDICAL | 2022-04-11 |
| PSW 2201.U/1 and NEO 2201.U/1 (P950037/S234) | Biotronik, Inc. | 2022-04-11 |
| 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/S775) | Medtronic Cardiac Rhythm Disease Management | 2022-04-11 |
| Edwards Alterra Adaptive Prestent System (P200015/S019) | Edwards Lifesciences, LLC | 2022-04-08 |
| Harmony Transcatheter Pulmonary Valve (P200046/S008) | Medtronic, Inc. | 2022-04-08 |
| Impella 5.5 with SmartAssist (P140003/S093) | Abiomed, Inc. | 2022-04-08 |
| SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste (P210014/S001) | Advanced Bifurcation Systems, Inc. | 2022-04-08 |
| KONECT RESILIA Aortic Valved Conduit (P150048/S063) | Edwards Lifesciences, LLC | 2022-04-08 |
| IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S062) | Medtronic, Inc. | 2022-04-07 |