| Micra AV TPS, Micra TPS (P150033/S132) | Medtronic, Inc. | 2022-01-28 |
| CapSure Epicardial Pacing Lead (P950024/S102) | Medtronic, Inc. | 2022-01-28 |
| 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/S702) | Medtronic, Inc. | 2022-01-28 |
| Attain Bipolar OTW Lead, Attain OTW LV Lead (P010015/S490) | Medtronic, Inc. | 2022-01-28 |
| CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S236) | Medtronic, Inc. | 2022-01-28 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S202) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S185) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S148) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S168) | Medtronic, Inc. | 2022-01-28 |
| 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/S804) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| HeartMate II Left Ventricular Assist System (P060040/S083) | ABBOTT MEDICAL | 2022-01-28 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S491) | Medtronic, Inc. | 2022-01-28 |
| Sprint Quattro Lead (P920015/S264) | Medtronic, Inc. | 2022-01-28 |
| CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead (P890003/S451) | Medtronic, Inc. | 2022-01-28 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S087) | W. L. Gore & Associates, Inc. | 2022-01-28 |
| CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S160) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| HeartMate 3 Left Ventricular Assist System (P160054/S045) | ABBOTT MEDICAL | 2022-01-28 |
| CapSureFix MRI Lead (P090013/S319) | Medtronic, Inc. | 2022-01-28 |
| 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/S770) | Medtronic Cardiac Rhythm Disease Management | 2022-01-28 |
| Venaseal Closure System (P140018/S026) | Medtronic Vascular, Inc. | 2022-01-27 |
| Talent Occluder With Occluder Delivery System (P100021/S093) | Medtronic Vascular | 2022-01-27 |
| Harmony Delivery Catheter System (DCS) and Loading System (P200046/S003) | Medtronic, Inc. | 2022-01-27 |
| Micra Transcatheter Pacemaker System (P150033/S107) | Medtronic, Inc. | 2022-01-27 |
| EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P (P130021/S095) | Medtronic, Inc. | 2022-01-27 |
| Resolute Integrity Coronary Stent System (P110013/S112) | Medtronic Vascular | 2022-01-27 |
| CardioMessenger Smart 4G (P050023/S164) | Biotronik, Inc. | 2022-01-27 |
| Integrity Coronary Stent System (P030009/S104) | Medtronic, Ireland | 2022-01-27 |
| Resolute Onyx Coronary Stent System (P160043/S048) | Medtronic Vascular | 2022-01-27 |
| GORE CARDIOFORM Septal Occluder (P050006/S097) | W. L. Gore & Associates, Inc. | 2022-01-27 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S061) | Medtronic, Inc. | 2022-01-27 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P190008/S015) | Medtronic Vascular, Inc. | 2022-01-27 |
| LifeVest® Wearable Defibrillator (P010030/S155) | Zoll Manufacturing Corporation | 2022-01-26 |
| LifeVest® Wearable Defibrillator (P010030/S157) | Zoll Manufacturing Corporation | 2022-01-25 |
| Rotablator/ROTAPRO Rotational Atherectomy System (P900056/S196) | Boston Scientific Corp | 2022-01-25 |
| CareLink SmartSync Cobalt Crome Application (P010031/S762) | Medtronic Cardiac Rhythm Disease Management | 2022-01-24 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S139) | Edwards Lifesciences, LLC | 2022-01-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P200015/S017) | Edwards Lifesciences, LLC | 2022-01-23 |
| 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/S701) | Medtronic, Inc. | 2022-01-21 |
| Micra AV TPS, Micra TPS (P150033/S131) | Medtronic, Inc. | 2022-01-21 |
| 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/S803) | Medtronic Cardiac Rhythm Disease Management | 2022-01-21 |
| 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/S769) | Medtronic Cardiac Rhythm Disease Management | 2022-01-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S489) | Medtronic, Inc. | 2022-01-21 |
| Zenith Fenestrated AAA Endovascular Graft (P020018/S060) | Cook, Inc. | 2022-01-20 |
| Medtronic Open Pivot Mechanical Valve (OPHV), Medtronic Open Pivot Aortic Valved Graft (AVG) (P990046/S060) | Medtronic Ats Medical, Inc. | 2022-01-20 |
| Arctic Front Advance, Arctic Front Advance Pro TM Cardiac Cryoablation Catheter (P100010/S124) | Medtronic Cryocath, LP | 2022-01-20 |
| Micra AV TPS, Micra TPS (P150033/S130) | Medtronic, Inc. | 2022-01-18 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S010) | Boston Scientific Corporation | 2022-01-18 |
| Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG (P980035/S700) | Medtronic, Inc. | 2022-01-18 |
| Amplatzer Duct Occluder, Amplatzer Duct Occluder II (P020024/S066) | ABBOTT MEDICAL | 2022-01-13 |
| Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT (P910023/S442) | ABBOTT MEDICAL | 2022-01-13 |
| Amplatzer Septal Occluder and Amplatzer Cribriform Occluder (P000039/S076) | ABBOTT MEDICAL | 2022-01-13 |
| Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent Systems (P160043/S057) | Medtronic Vascular | 2022-01-13 |
| Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF; (P030054/S397) | ABBOTT MEDICAL | 2022-01-13 |
| Amplatzer Muscular VSD Occluder (P040040/S045) | ABBOTT MEDICAL | 2022-01-13 |
| Amplatzer PFO Occluder (P120021/S022) | ABBOTT MEDICAL | 2022-01-13 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S044) | ABBOTT MEDICAL | 2022-01-12 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S082) | ABBOTT MEDICAL | 2022-01-12 |
| 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/S694) | Medtronic, Inc. | 2022-01-12 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S033) | Medtronic Vascular, Inc. | 2022-01-11 |
| EPi-Sense Guided Coagulation System (P200002/S001) | AtriCure, Inc. | 2022-01-10 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S488) | Medtronic, Inc. | 2022-01-10 |
| 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/S699) | Medtronic, Inc. | 2022-01-10 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S071) | ABBOTT MEDICAL | 2022-01-07 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S441) | ABBOTT MEDICAL | 2022-01-07 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S396) | ABBOTT MEDICAL | 2022-01-07 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S188) | ABBOTT MEDICAL | 2022-01-07 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers. (P880086/S322) | ABBOTT MEDICAL | 2022-01-07 |
| Microny family of Pacemakers (P970013/S089) | ABBOTT MEDICAL | 2022-01-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S043) | ABBOTT MEDICAL | 2022-01-07 |
| 9600CR Crimper (P140031/S138) | Edwards Lifesciences, LLC | 2022-01-04 |
| Shockwave C2 Intravascular (IVL) Catheter, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) (P200039/S004) | Shockwave Medical, Inc. | 2022-01-04 |
| 9600CR Crimper (P200015/S016) | Edwards Lifesciences, LLC | 2022-01-04 |
| Endurant Stent Graft System, Endurant II Stent Graft System (P100021/S099) | Medtronic Vascular | 2022-01-03 |
| Subcutaneous Implantable Cardiac Defibrillators, Emblem MRI S-ICD, Emblem S-ICD (P110042/S166) | Boston Scientific Corporation | 2021-12-29 |
| SmartAblate Irrigation Tubing Set (P990071/S047) | Biosense Webster, Inc. | 2021-12-23 |
| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (AngioSculpt Evo catheter) (P050018/S030) | Spectranetics Corp. | 2021-12-23 |
| Innova Vascular Self-Expanding Stent System (P140028/S070) | Boston Scientific Corporation | 2021-12-23 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S046) | Boston Scientific Corp | 2021-12-23 |
| U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S216) | Guidant Corp. | 2021-12-23 |
| L100 ESSENTIO SR, L101 ESSENTIO DR, L121 ESSENTIO EL DR, L200 PROPONENT SR, L201 PROPONENT DR, L221 PROPONENT EL D (N970003/S271) | Boston Scientific Corp | 2021-12-23 |
| RELIANCE 4-FRONT (P910073/S165) | Boston Scientific | 2021-12-23 |
| L110 ESSENTIO MRI SR, L111 ESSENTIO MRI DR, L131 ESSENTIO MRI EL DR, L210 PROPONENT, L211 PROPONENT, L231 PROPONENT, (P150012/S121) | Boston Scientific | 2021-12-23 |
| AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder (P120021/S023) | ABBOTT MEDICAL | 2021-12-22 |
| 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/S231) | Biotronik, Inc. | 2021-12-22 |
| 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/S133) | Biotronik, Inc. | 2021-12-22 |
| ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT (P140016/S004) | Cook Medical Incorporated | 2021-12-22 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI (P960040/S474) | Boston Scientific | 2021-12-21 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S801) | Medtronic Cardiac Rhythm Disease Management | 2021-12-21 |
| ORIGEN CRT-D, ORIGEN X4 CRT-D, MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN (P010012/S549) | Boston Scientific Corp | 2021-12-21 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR (N970003/S272) | Boston Scientific Corp | 2021-12-21 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D, (P010031/S767) | Medtronic Cardiac Rhythm Disease Management | 2021-12-21 |
| SICD Gen 2, SICD MRI (P110042/S168) | Boston Scientific Corporation | 2021-12-21 |
| Scoreflex NC Scoring PTCA Catheter (P200041) | OrbusNeich Medical (Shenzhen) Co., Ltd. | 2021-12-21 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S217) | Guidant Corp. | 2021-12-21 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S122) | Boston Scientific | 2021-12-21 |
| GORE CARDIOFORM Septal Occluder (P050006/S093) | W. L. Gore & Associates, Inc. | 2021-12-21 |
| Endurant Stent Graft System (P100021/S098) | Medtronic Vascular | 2021-12-20 |
| HeartMate 3 Left Ventricular Assist System (P160054/S041) | ABBOTT MEDICAL | 2021-12-20 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S110) | Biotronik, Inc. | 2021-12-20 |
| 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/S698) | Medtronic, Inc. | 2021-12-17 |