| ENDOTAK Lead System (P910073/S163) | Boston Scientific | 2021-09-24 |
| GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S085) | W. L. Gore & Associates, Inc. | 2021-09-24 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S112) | Abbott Vascular, Inc. | 2021-09-24 |
| CONTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, ENERGEN CRT-D, PUNCTUA CRT-D, INCEPTA CRT-D, ORIGEN CRT-D, INOGEN CRT-D, DYNA (P010012/S542) | Boston Scientific Corp | 2021-09-24 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava CRT-D, Brava Quad CRT-D,Brava Quad CRT-D, Claria MRI CRT-D, (P010031/S757) | Medtronic Cardiac Rhythm Disease Management | 2021-09-23 |
| Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Vers (P980035/S691) | Medtronic, Inc. | 2021-09-23 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD,Crome MRI ICD, Evera MRI DF-1 ICD, E (P980016/S792) | Medtronic Cardiac Rhythm Disease Management | 2021-09-23 |
| Stockert SMARTABLATE System (P990071/S046) | Biosense Webster, Inc. | 2021-09-23 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sol (P010015/S483) | Medtronic, Inc. | 2021-09-23 |
| NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER and THERMOCOOL SMARTTOUCH (P040036/S082) | Biosense Webster, Inc. | 2021-09-22 |
| TactiCath Contact Force Ablation Catheter Sensor Enabled (P130026/S075) | St Jude Medical | 2021-09-22 |
| Biosense Webster Cables (P990071/S052) | Biosense Webster, Inc. | 2021-09-22 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S078) | Boston Scientific Corporation | 2021-09-22 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S001) | ABBOTT MEDICAL | 2021-09-22 |
| Amplatzer Septal Occluder (P000039/S075) | ABBOTT MEDICAL | 2021-09-22 |
| Celsius RMT ThermoCool Catheter, Celsius ThermoCool Catheter, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Cath (P030031/S124) | Biosense Webster, Inc. | 2021-09-22 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System; Promus ELITE Everolimus-Eluting Platinum Chro (P110010/S198) | Boston Scientific Corp | 2021-09-22 |
| Evolut FX device (P130021/S103) | Medtronic, Inc. | 2021-09-22 |
| CELSIUS and EZ STEER (P990025/S065) | Biosense Webster, Inc. | 2021-09-22 |
| Biosense Webster Cables, Celsius DS Catheter, Celsius FLTR, EZ Steer Nav DS Catheter, NaviStar DS Catheter, NaviStar RMT (P010068/S068) | Biosense Webster, Inc. | 2021-09-22 |
| Biosense Webster Cables, Celsius Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter,EZ Steer Catheter, EZ (P950005/S083) | Biosense Webster, Inc. | 2021-09-22 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S114) | Abbott Vascular, Inc. | 2021-09-22 |
| 9600TFX Edwards SAPIEN 3 Transcatheter Heart Valves, 9750TFX Edwards SAPIEN 3 Ultra Transcatheter Heart Valves (P140031/S134) | Edwards Lifesciences, LLC | 2021-09-22 |
| CELSIUS THERMOCOOL, THERMOCOOL SF, THERMOCOOL SMARTTOUCH SF, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, and THERMOCOOL SM (P030031/S120) | Biosense Webster, Inc. | 2021-09-22 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter Sensor Enabled (P110016/S078) | ABBOTT MEDICAL | 2021-09-22 |
| Wolverine Coronary Cutting Balloon (P950020/S113) | Boston Scientific Corp | 2021-09-22 |
| EZ Steer ThermoCool Catheter, EZ Steer ThermoCool Nav Catheter, NaviStar RMT ThermoCool Catheter, NaviStar ThermoCool C (P040036/S086) | Biosense Webster, Inc. | 2021-09-22 |
| CELSIUS, NAVISTAR and EZ STEER (P010068/S065) | Biosense Webster, Inc. | 2021-09-22 |
| Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System,9600TFXEdwards SAPIEN 3 Transca (P200015/S013) | Edwards Lifesciences, LLC | 2021-09-22 |
| CELSIUS DS, NAVISTAR DS, EZ STEER DS and CELSIUS FLTR (P950005/S080) | Biosense Webster, Inc. | 2021-09-22 |
| Biosense Webster Cables, EZ Steer Nav Catheter, NaviStar Catheter, NaviStar RMT Catheter (P990025/S068) | Biosense Webster, Inc. | 2021-09-22 |
| CardioMEMS HF System (P100045/S049) | ABBOTT MEDICAL | 2021-09-21 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN (P960040/S469) | Boston Scientific | 2021-09-20 |
| ICD ORIGEN CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D (P010012/S544) | Boston Scientific Corp | 2021-09-20 |
| EMBLEM S-ICD (P110042/S157) | Boston Scientific Corporation | 2021-09-17 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S230) | Medtronic, Inc. | 2021-09-17 |
| Portico Transcatheter Aortic Valve Implantation System (P190023) | ABBOTT MEDICAL | 2021-09-17 |
| AngelMed Guardian® System (P150009/S006) | Avertix Medical, Inc. | 2021-09-17 |
| INGENIO MRI, VITALIO MRI, VORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S114) | Boston Scientific | 2021-09-17 |
| INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S211) | Guidant Corp. | 2021-09-17 |
| LATITUDE NXT Remote Patient Management System, LATITUDEWave Communicator, LATITUDE Consult Communicator, LATITUDE NX (P910077/S185) | Boston Scientific | 2021-09-17 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA (P960040/S465) | Boston Scientific | 2021-09-17 |
| ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT (N970003/S266) | Boston Scientific Corp | 2021-09-17 |
| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S539) | Boston Scientific Corp | 2021-09-17 |
| SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve Systems (P140031/S130) | Edwards Lifesciences, LLC | 2021-09-17 |
| LifeVest Wearable Defibrillator (P010030/S151) | Zoll Manufacturing Corporation | 2021-09-17 |
| Epic, Epic Supra and Epic Plus Tissue Heart Valves (P040021/S047) | ABBOTT MEDICAL | 2021-09-17 |
| CardioMEMS HF System (P100045/S058) | ABBOTT MEDICAL | 2021-09-16 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra, Assura, Epic+/HF/HF+/II HF/II+ (P030054/S389) | ABBOTT MEDICAL | 2021-09-15 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S184) | ABBOTT MEDICAL | 2021-09-15 |
| Micra AV TPS, Micra TPS (P150033/S118) | Medtronic, Inc. | 2021-09-15 |
| Tridyne Vascular Sealant (P150016/S021) | Neomend, Inc. | 2021-09-15 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S317) | ABBOTT MEDICAL | 2021-09-15 |
| Zenex MRI, Zenus MRI (P140033/S070) | ABBOTT MEDICAL | 2021-09-15 |
| Assurity MRI and Endurity MRI family of Pacemakers (P140033/S065) | ABBOTT MEDICAL | 2021-09-15 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S435) | ABBOTT MEDICAL | 2021-09-15 |
| QUIK-COMBO® Therapy Cable (a necessary AED accessory of the LIFEPAK® 15 Monitor/Defibrillator) (P160026/S029) | Physio-Control, Inc. | 2021-09-15 |
| Microny family of Pacemakers (P970013/S085) | ABBOTT MEDICAL | 2021-09-15 |
| Sprint Quattro Lead (P920015/S256) | Medtronic, Inc. | 2021-09-15 |
| Endurity Core, Endurity, Zenex, Zenus (P880086/S321) | ABBOTT MEDICAL | 2021-09-15 |
| Ellipse VR DR, Fortify Assura VR DR (P910023/S439) | ABBOTT MEDICAL | 2021-09-15 |
| Quadra Assura MP, Quadra Assura, Unify Assura (P030054/S394) | ABBOTT MEDICAL | 2021-09-15 |
| HeartWare Ventricular Assist System (P100047/S173) | Medtronic | 2021-09-14 |
| Innova Vascular Self-Expanding Stent System (P140028/S068) | Boston Scientific Corporation | 2021-09-13 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S044) | Boston Scientific Corp | 2021-09-13 |
| Innova Self-Expanding Stent System (P140028/S069) | Boston Scientific Corporation | 2021-09-10 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1 (P980016/S791) | Medtronic Cardiac Rhythm Disease Management | 2021-09-10 |
| Amplia MRI CRTD, Amplia MRI Quad, Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Clari (P010031/S756) | Medtronic Cardiac Rhythm Disease Management | 2021-09-10 |
| Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S095) | Medtronic Vascular | 2021-09-10 |
| Freezor, Freezor Xtra and Freezor MAX Cardiac Cryoablation Catheter, Electrical Umbilical and Coax Umbilical cable (P020045/S097) | Medtronic Cryocath, LP | 2021-09-10 |
| Arctic Front Advance, Arctic Front Advance Pro Cardiac Cryoablation Catheter and Manual Retraction Kit (P100010/S117) | Medtronic Cryocath, LP | 2021-09-10 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S045) | Boston Scientific Corp | 2021-09-10 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S010) | Defibtech, LLC | 2021-09-10 |
| Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S063) | Corcym S.r.l. | 2021-09-09 |
| WATCHMAN Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S046) | Boston Scientific Corp | 2021-09-09 |
| Carpentier-Edwards PERIMOUNT Theon RSR Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwar (P860057/S203) | Edwards Lifesciences, LLC | 2021-09-08 |
| Edwards INSPIRIS RESILIA Aortic Valve (P150048/S057) | Edwards Lifesciences, LLC | 2021-09-08 |
| 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/S690) | Medtronic, Inc. | 2021-09-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S482) | Medtronic, Inc. | 2021-09-08 |
| Edwards INTUITY Elite Valve (P150036/S056) | Edwards Lifesciences, LLC | 2021-09-08 |
| Tack Endovascular System (6F) (P180034/S005) | Philips Image Guided Therapy Corporation | 2021-09-07 |
| THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter, T (P030031/S123) | Biosense Webster, Inc. | 2021-09-07 |
| IntellaNav Open Irrigated Ablation Catheters, IntellaNav MiFi Open-Irrigated Ablation Catheters (P150005/S067) | Boston Scientific Corp | 2021-09-07 |
| IntellaNav MiFi XP, IntellaNav XP (P020025/S133) | Boston Scientific | 2021-09-07 |
| Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S113) | Abbott Vascular, Inc. | 2021-09-07 |
| IntellaNav ST (P920047/S125) | Boston Scientific Corp | 2021-09-07 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S022) | Lutonix | 2021-09-07 |
| THERMOCOOL SMARTTOUCH® Uni-Directional Navigation Catheter, THERMOCOOL SMARTTOUCH® Bi-Directional Navigation Catheter (P040036/S085) | Biosense Webster, Inc. | 2021-09-07 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S132) | Edwards Lifesciences, LLC | 2021-09-03 |
| VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S210) | Guidant Corp. | 2021-09-03 |
| Sentus QP leads (P070008/S129) | Biotronik, Inc. | 2021-09-03 |
| Organ Care System (OCS) Heart System (P180051) | TransMedics, Inc. | 2021-09-03 |
| ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE (N970003/S265) | Boston Scientific Corp | 2021-09-03 |
| ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S112) | Boston Scientific | 2021-09-03 |
| Spectranetics Laser Sheath (SLS) (P910001/S112) | Spectranetics Corp. | 2021-09-02 |
| Glidelight Laser Sheath (P960042/S070) | Spectranetics (Philips) | 2021-09-02 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, (P030054/S395) | ABBOTT MEDICAL | 2021-09-01 |
| 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/S790) | Medtronic Cardiac Rhythm Disease Management | 2021-09-01 |
| 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 M (P010031/S755) | Medtronic Cardiac Rhythm Disease Management | 2021-09-01 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S032) | W. L. Gore & Associates, Inc. | 2021-09-01 |