| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S102) | Medtronic Vascular | 2022-04-07 |
| DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM (P130005/S034) | Cardiovascular Systems, Inc. | 2022-04-06 |
| Impella CP with SmartAssist (P140003/S092) | Abiomed, Inc. | 2022-04-05 |
| BioMimics 3D Vascular Stent System (P180003/S006) | Veryan Medical, Ltd. | 2022-04-05 |
| Zilver Vascular Stent (P050017/S019) | Cook Ireland, Ltd. | 2022-04-04 |
| HeartLight® X3 Catheter with Excalibur Balloon (P150026/S013) | Cardiofocus, Inc. | 2022-04-02 |
| CentriMag Circulatory Support System (P170038/S009) | Abbott | 2022-04-01 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S777) | Medtronic Cardiac Rhythm Disease Management | 2022-04-01 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S810) | Medtronic Cardiac Rhythm Disease Management | 2022-04-01 |
| CardioMEMS HF System (P100045/S061) | ABBOTT MEDICAL | 2022-03-31 |
| EDWARDS INTUITY Elite Valve (P150036/S060) | Edwards Lifesciences, LLC | 2022-03-31 |
| Carpentier-Edwards PERIMOUNT Magna Ease® Pericardial Aortic Bioprosthesis with ThermaFix tissue process (P860057/S206) | Edwards Lifesciences, LLC | 2022-03-31 |
| EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De (P130021/S114) | Medtronic, Inc. | 2022-03-31 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S061) | Edwards Lifesciences, LLC | 2022-03-31 |
| Aveir VR Leadless System (P150035) | ABBOTT MEDICAL | 2022-03-31 |
| WOLVERINE Coronary Cutting Balloon (P950020/S118) | Boston Scientific Corp | 2022-03-31 |
| Wolverine Coronary Cutting Balloon (P950020/S120) | Boston Scientific Corp | 2022-03-30 |
| ROTAPRO Rotational Atherectomy System (P900056/S198) | Boston Scientific Corp | 2022-03-30 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S203) | Boston Scientific Corp | 2022-03-30 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S084) | Boston Scientific Corporation | 2022-03-30 |
| LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1 (P150012/S124) | Boston Scientific | 2022-03-29 |
| CapSure Sense Lead (P830061/S205) | Medtronic Cardiac Rhythm Disease Management | 2022-03-29 |
| CapSureFix Novus Lead (P930039/S240) | Medtronic, Inc. | 2022-03-29 |
| Adapta, Versa, Sensia, Astra S DR MRI IPG, Astra S SR MRI IPG,Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR MRI I (P980035/S711) | Medtronic, Inc. | 2022-03-29 |
| Stellarex 0.035OTW Drug-coated Angioplasty Balloon (P160049/S015) | The Spectranetics Corp. | 2022-03-25 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S034) | Boston Scientific Corp | 2022-03-24 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S809) | Medtronic Cardiac Rhythm Disease Management | 2022-03-24 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S776) | Medtronic Cardiac Rhythm Disease Management | 2022-03-24 |
| On X Prosthetic Heart Valve Ascending Aortic Prothesis (P000037/S059) | On-X Life Technologies, Inc. | 2022-03-24 |
| 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/S710) | Medtronic, Inc. | 2022-03-24 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt (P130021/S111) | Medtronic, Inc. | 2022-03-24 |
| Covera Vascular Covered Stent (P170042/S011) | C.R. Bard, Inc. | 2022-03-24 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S494) | Medtronic, Inc. | 2022-03-24 |
| RX Herculink Elite Renal Stent System (P110001/S018) | Abbott Vascular | 2022-03-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S039) | ABBOTT MEDICAL | 2022-03-24 |
| 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/S708) | Medtronic, Inc. | 2022-03-23 |
| 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/S709) | Medtronic, Inc. | 2022-03-23 |
| 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/S774) | Medtronic Cardiac Rhythm Disease Management | 2022-03-23 |
| 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/S808) | Medtronic Cardiac Rhythm Disease Management | 2022-03-23 |
| Shockwave Medical, Inc. IVL Generator and Connector Cable Kit, Shockwave C2 Coronary IVL Catheter (P200039/S006) | Shockwave Medical, Inc. | 2022-03-23 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S493) | Medtronic, Inc. | 2022-03-23 |
| Medtronic CoreValve EnVeo R Loading System, Medtronic CoreValve EnVeo Pro Loading System, Medtronic Evolut Pro+ Loa (P130021/S112) | Medtronic, Inc. | 2022-03-21 |
| HeartStart FRx Defibrillator (P180028/S012) | Philips Medical Systems | 2022-03-20 |
| HeartStart OnSite Home Defibrillator (P160029/S015) | Philips Medical Systems, Inc. | 2022-03-20 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S151) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S034) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S090) | W. L. Gore & Associates, Inc. | 2022-03-18 |
| DiamondTemp Radiofrequency Generator (P200028/S008) | Medtronic, Inc. | 2022-03-17 |
| HeartWare Ventricular Assist (HVAD) System (P100047/S195) | Medtronic | 2022-03-16 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S125) | Medtronic Cryocath, LP | 2022-03-16 |
| OPTIMIZER Smart Mini System (P180036/S009) | Impulse Dynamics (Usa), Inc. | 2022-03-16 |
| MITRIS RESILIA Mitral Valve (P150048/S047) | Edwards Lifesciences, LLC | 2022-03-16 |
| Impella RP and Impella RP with SmartAssist (P170011/S036) | Abiomed, Inc. | 2022-03-16 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD and Impella 5.5 with SmartAssist (P140003/S091) | Abiomed, Inc. | 2022-03-16 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S706) | Medtronic, Inc. | 2022-03-15 |
| SmartAblate Irrigation Tubing Set (P990071/S053) | Biosense Webster, Inc. | 2022-03-15 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S112) | Biotronik, Inc. | 2022-03-15 |
| Freezor Cardiac Cryoablation Catheter, Freezor Xtra Cardiac Cryoablation Catheter, Freezor MAX Cardiac Cryoablation Cath (P020045/S100) | Medtronic Cryocath, LP | 2022-03-15 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit (P100010/S126) | Medtronic Cryocath, LP | 2022-03-15 |
| Drug Eluting Permanent Right Ventricular/Right Atrial Pacemaker Electrodes (P950037/S235) | Biotronik, Inc. | 2022-03-15 |
| Heartware Ventricular Assist System (P100047/S194) | Medtronic | 2022-03-15 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S238) | Medtronic, Inc. | 2022-03-14 |
| SelectSecure Lead (P030036/S136) | Medtronic Cardiac Rhythm Disease Management | 2022-03-14 |
| Attain Stability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S169) | Medtronic, Inc. | 2022-03-14 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S203) | Medtronic Cardiac Rhythm Disease Management | 2022-03-14 |
| Medtronic Open Pivot Heart Valve, Medtronic Open Pivot Aortic Valved Graft (P990046/S063) | Medtronic Ats Medical, Inc. | 2022-03-11 |
| Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System (P150036/S057) | Edwards Lifesciences, LLC | 2022-03-11 |
| HeartWare® HVAD System (P100047/S193) | Medtronic | 2022-03-11 |
| Diamondback 360 Coronary Orbital Atherectomy System (P130005/S035) | Cardiovascular Systems, Inc. | 2022-03-11 |
| XIENCE Skypoint Everolimus Eluting Coronary Stent System (P110019/S118) | Abbott Vascular | 2022-03-11 |
| TherOx Downstream System (P170027/S009) | Zoll Circulation, Inc. | 2022-03-10 |
| Open Pivot Heart Valve, Open Pivot Aortic Valved Graft (P990046/S064) | Medtronic Ats Medical, Inc. | 2022-03-10 |
| Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG) (P990046/S062) | Medtronic Ats Medical, Inc. | 2022-03-10 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S117) | Boston Scientific Corp | 2022-03-09 |
| Dual Sensor (DS) Catheters (P010068/S067) | Biosense Webster, Inc. | 2022-03-08 |
| CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH, THERMOCOOL SMARTTOU (P030031/S122) | Biosense Webster, Inc. | 2022-03-08 |
| NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (P040036/S084) | Biosense Webster, Inc. | 2022-03-08 |
| INGEVITY MRI pace/sense lead (P150012/S123) | Boston Scientific | 2022-03-08 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S707) | Medtronic, Inc. | 2022-03-08 |
| nGEN Pump (P990071/S051) | Biosense Webster, Inc. | 2022-03-08 |
| FINELINE II pace/sense lead (P960004/S099) | Boston Scientific | 2022-03-08 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico (P070008/S134) | Biotronik, Inc. | 2022-03-08 |
| Impella RP, Impella RP with SmartAssist (P170011/S037) | Abiomed, Inc. | 2022-03-08 |
| NAVISTAR (P990025/S067) | Biosense Webster, Inc. | 2022-03-08 |
| Cordis® PALMAZ® Balloon-Expandable Stent (P890017/S022) | Cordis US Corporation | 2022-03-08 |
| RELIANCE 4-FRONT defibrillation pace/sense lead, ENDOTAK RELIANCE defibrillation pace/sense lead (P910073/S168) | Boston Scientific | 2022-03-08 |
| ACUITY Spiral Coronary Venous Pace/Sense Lead, ACUITY X4 Coronary Venous Pace/Sense Lead (P010012/S551) | Boston Scientific Corp | 2022-03-08 |
| 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, Enticos (P950037/S232) | Biotronik, Inc. | 2022-03-08 |
| Acticor 7 VR-T, Rivacor 7 VR-T, Rivacor 5 VR-T, Rivacor 3 VR-T, Acticor 7 VR-T DX, Rivacor 7 VR-T DX, Rivacor 5 VR-T DX, (P050023/S165) | Biotronik, Inc. | 2022-03-08 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S095) | Abiomed, Inc. | 2022-03-08 |
| CELSIUS (P950005/S082) | Biosense Webster, Inc. | 2022-03-08 |
| Solo Smart Stentless Heart Valve (P130011/S010) | Corcym Canada Corp | 2022-03-07 |
| Portico (P190023/S005) | ABBOTT MEDICAL | 2022-03-07 |
| Perceval S Sutureless Heart Valve, Perceval Plus Sutureless Heart Valve (P150011/S023) | Corcym S.r.l. | 2022-03-07 |
| Carbomedics® Prosthetic Heart Valve, Carbomedics® Supra-annular Prosthetic Heart Valve (Top Hat), Carbo-Seal® Ascending (P900060/S064) | Corcym S.r.l. | 2022-03-07 |
| Freezor Max Cardiac Cryoablation Catheter (P100010/S123) | Medtronic Cryocath, LP | 2022-03-07 |
| DiamondTemp Ablation Catheters (P200028/S010) | Medtronic, Inc. | 2022-03-04 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S024) | Berlin Heart, Inc. | 2022-03-04 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S018) | Medtronic Vascular, Inc. | 2022-03-04 |
| Portico Transcatheter Aortic Heart Valve (P190023/S006) | ABBOTT MEDICAL | 2022-03-04 |