| VIGOR DR/SR, DISCOVERY, and MERIDIAN (P940031/S079) | Boston Scientific | 2021-04-02 |
| VENTAK (P830060/S085) | Boston Scientific | 2021-04-02 |
| VENTAK P (P890061/S024) | Boston Scientific | 2021-04-02 |
| INGEVITY MRI Pace/Sense Leads (P150012/S108) | Boston Scientific | 2021-04-02 |
| DELTA/VISTA (P840068/S055) | Boston Scientific | 2021-04-02 |
| VENTAK PRx and VENTAK MINI (P910077/S183) | Boston Scientific | 2021-04-02 |
| Contak CD, Contak Renewal, Livian, Cognis, Energen CRT-D, Punctua CRT-D, Incepta CRT-D, Origen CRT-D, Inogen CRT-D, Dyna (P010012/S533) | Boston Scientific Corp | 2021-04-02 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S155) | Boston Scientific Corporation | 2021-04-02 |
| VENTAK AV & VENTAK PRIZM DR/VR, VITALITY, CONFIENT, TELIGEN, PUNCTUA ICD, ENERGEN ICD, INCEPTA ICD, ORIGEN ICD, INOGEN I (P960040/S462) | Boston Scientific | 2021-04-02 |
| VENTAK P2 System (P930035/S031) | Boston Scientific | 2021-04-02 |
| Contak Renewal TR, Valitude, Invive, and Intua (P030005/S207) | Guidant Corp. | 2021-04-02 |
| SWEET TIP Rx, SWEET PICOTIO Rx, and FLEXTEND (P960006/S051) | Boston Scientific | 2021-04-02 |
| THINLINE/FINELINE Family of Endocardial Pacing Leads (P960004/S093) | Boston Scientific | 2021-04-02 |
| Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S728) | Medtronic Cardiac Rhythm Disease Management | 2021-04-01 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S044) | Cordis US Corporation | 2021-04-01 |
| Cordis PRECISE Nitinol Stent System (P030047/S042) | Cordis US Corporation | 2021-04-01 |
| Enticos 4 DR, Enticos 4 D, Enticos 4 SR, Enticos 4 S, Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 (P950037/S219) | Biotronik, Inc. | 2021-04-01 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S009) | Boston Scientific Corporation | 2021-04-01 |
| PRECISE Pro Rx Nitinol Stent System (P030047/S041) | Cordis US Corporation | 2021-04-01 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P (P010015/S463) | Medtronic, Inc. | 2021-04-01 |
| Cordis S.M.A.R.T. CONTROL / S.M.A.R.T. Vascular Stent System (P120002/S019) | Cordis US Corporation | 2021-04-01 |
| SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S128) | Edwards Lifesciences, LLC | 2021-03-31 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S033) | Medinol, Ltd. | 2021-03-31 |
| Zenith Dissection Endovascular System (P180001/S002) | William Cook Europe Aps | 2021-03-31 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S031) | W. L. Gore & Associates, Inc. | 2021-03-31 |
| HeartWare HVAD System (P100047/S176) | Medtronic | 2021-03-30 |
| ENROUTE TRANSCAROTID STENT SYSTEM (P140026/S017) | Boston Scientific Corporation | 2021-03-30 |
| LOTUS Edge Valve System (P180029/S030) | Boston Scientific Corporation | 2021-03-30 |
| CapSure Sense Lead (P830061/S194) | Medtronic Cardiac Rhythm Disease Management | 2021-03-29 |
| TherOx Downstream System (P170027/S004) | Zoll Circulation, Inc. | 2021-03-29 |
| Sprint Quattro Lead (P920015/S254) | Medtronic, Inc. | 2021-03-29 |
| Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M (P980035/S680) | Medtronic, Inc. | 2021-03-29 |
| CapSureFix Novus Lead (P930039/S224) | Medtronic, Inc. | 2021-03-29 |
| Micra Transcatheter Pacing System and Micra AV TPS (P150033/S099) | Medtronic, Inc. | 2021-03-26 |
| THERMOCOOL SMARTTOUCH SF Catheter (P030031/S109) | Biosense Webster, Inc. | 2021-03-26 |
| TherOx Downstream System (P170027/S003) | Zoll Circulation, Inc. | 2021-03-26 |
| Harmony TPV System (P200046) | Medtronic, Inc. | 2021-03-26 |
| X Series, R Series, Propaq MD, and AED Pro (P160022/S027) | ZOLL Medical Corporation | 2021-03-26 |
| GORE TAG Thoracic Endoprosthesis and GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S124) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Cobaly MRI, XT MRI RT-D and Crome MRI CRT-D (P010031/S734) | Medtronic Cardiac Rhythm Disease Management | 2021-03-25 |
| Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG (P980035/S674) | Medtronic, Inc. | 2021-03-25 |
| GORE EXCLUDER Iliac Branch Endoprosthesis (P020004/S180) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Cobalt MRI ICD, Cobalt XT MRI ICD and Crombe MRI ICD (P980016/S772) | Medtronic Cardiac Rhythm Disease Management | 2021-03-25 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S030) | W. L. Gore & Associates, Inc. | 2021-03-25 |
| Attain Performa Lead and Attain Stability Quad MRI Lead (P080006/S160) | Medtronic, Inc. | 2021-03-25 |
| BSC WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S038) | Boston Scientific Corp | 2021-03-24 |
| Evolut PRO+ System (P130021/S089) | Medtronic, Inc. | 2021-03-24 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S190) | Boston Scientific Corp | 2021-03-24 |
| Therapy Cool Path Duo and Therapy Cool Flex (P110016/S074) | ABBOTT MEDICAL | 2021-03-24 |
| Therapy Cool Path (P060019/S051) | Irvine Biomedical, Inc. | 2021-03-24 |
| Therapy and Therapy Dual-8 (P040014/S043) | Irvine Biomedical, Inc. | 2021-03-24 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S072) | Boston Scientific Corp | 2021-03-24 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S148) | Abbott Vascular, Inc. | 2021-03-24 |
| Therapy and Therapy Dual-8 and Safire TX Ablation Catheter (P040042/S049) | Irvine Biomedical,Inc.(Ibi) | 2021-03-24 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S072) | Boston Scientific Corporation | 2021-03-24 |
| MULTI-LINK VISION, MULTI-LINK MINI VISION and MULTI-LINK 8 Coronary Stent Systems (P020047/S074) | Abbott Vascular | 2021-03-24 |
| XIENCE PRIME SV Everolimus Eluting Coronary Stent System, XIENCE PRIME Everolimus Eluting Coronary Stent System, XIENCE (P110019/S116) | Abbott Vascular | 2021-03-24 |
| HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) (P160054/S035) | ABBOTT MEDICAL | 2021-03-23 |
| KONECT RESILIA Aortic Valved Conduit (AVC) (P150048/S052) | Edwards Lifesciences, LLC | 2021-03-23 |
| Bard E-Luminexx Vascular Stent (P080007/S024) | Bard Peripheral Vascular, Inc. | 2021-03-23 |
| Bard Fluency Plus Endovascular Stent Graft (P130029/S009) | Bard Peripheral Vascular, Inc. | 2021-03-23 |
| VenaSeal Closure System (P140018/S022) | Medtronic Vascular, Inc. | 2021-03-22 |
| HeartMate 3 Left Ventricular Assist System (P160054/S034) | ABBOTT MEDICAL | 2021-03-21 |
| HeartMate II Left Ventricular Assist System (P060040/S079) | ABBOTT MEDICAL | 2021-03-21 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S127) | Edwards Lifesciences, LLC | 2021-03-19 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System (P200015/S008) | Edwards Lifesciences, LLC | 2021-03-19 |
| SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S071) | Boston Scientific Corporation | 2021-03-19 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S113) | Edwards Lifesciences, LLC | 2021-03-19 |
| LIFEPAK 15 Monitor/Defibrillator and LIFEPAK 20e Defibrillator/Monitor (P160026/S024) | Physio-Control, Inc. | 2021-03-19 |
| QuickFlex µ and Quartet (P030054/S390) | ABBOTT MEDICAL | 2021-03-18 |
| IsoFlex (P960030/S073) | ABBOTT MEDICAL | 2021-03-18 |
| ZOLL AED 3 and ZOLL AED 3 Automatic (P160015/S011) | ZOLL Medical Corporation | 2021-03-18 |
| ZOLL AED 3 BLS (P160022/S026) | ZOLL Medical Corporation | 2021-03-18 |
| Perceval Sutureless Heart Valve, Perceval PLUS (P150011/S022) | Corcym S.r.l. | 2021-03-17 |
| Medical Mechanical Heart Valve (P810002/S110) | ABBOTT MEDICAL | 2021-03-17 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter, 9F Freezor MAX Cardiac Cryoabla (P020045/S094) | Medtronic Cryocath, LP | 2021-03-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD (P980016/S777) | Medtronic Cardiac Rhythm Disease Management | 2021-03-16 |
| Tack Endovascular System (P180034/S004) | Philips Image Guided Therapy Corporation | 2021-03-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S739) | Medtronic Cardiac Rhythm Disease Management | 2021-03-16 |
| Micra AV TPS, Micra TPS (P150033/S097) | Medtronic, Inc. | 2021-03-16 |
| Ranger Over-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S007) | Boston Scientific Corporation | 2021-03-15 |
| CardioMEMS HF System (P100045/S047) | ABBOTT MEDICAL | 2021-03-12 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S076) | Abiomed, Inc. | 2021-03-12 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S087) | Medtronic, Inc. | 2021-03-12 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S044) | Medtronic Vascular | 2021-03-12 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S471) | Medtronic, Inc. | 2021-03-12 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-directional Ablation Catheter (P960016/S086) | St Jude Medical | 2021-03-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S013) | Medtronic Vascular, Inc. | 2021-03-12 |
| Impella RP (P170011/S027) | Abiomed, Inc. | 2021-03-12 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S048) | Irvine Biomedical,Inc.(Ibi) | 2021-03-12 |
| Cobalt MRI ICD, CObalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/SR ICD, Evera XT DR/VR I (P980016/S776) | Medtronic Cardiac Rhythm Disease Management | 2021-03-12 |
| 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/S738) | Medtronic Cardiac Rhythm Disease Management | 2021-03-12 |
| Integrity Coronary Stent System (P030009/S100) | Medtronic, Ireland | 2021-03-12 |
| 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/S678) | Medtronic, Inc. | 2021-03-12 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S050) | Irvine Biomedical, Inc. | 2021-03-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S058) | Medtronic, Inc. | 2021-03-12 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S068) | St Jude Medical | 2021-03-12 |
| Therapy Ablation Catheters (P040014/S042) | Irvine Biomedical, Inc. | 2021-03-12 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther (P110016/S073) | ABBOTT MEDICAL | 2021-03-12 |
| Endurant Stent Grafyt System, Endurant II Stent Graft System, Ednurant II AUI Stent Graft System, Endurant IIs Stent Gra (P100021/S088) | Medtronic Vascular | 2021-03-12 |