| Home Monitoring System Version 3.52.0 (P000009/S095) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P980023/S108) | Biotronik, Inc. | 2025-04-15 |
| Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant (P910023/S476) | ABBOTT MEDICAL | 2025-04-15 |
| Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra (P030054/S432) | ABBOTT MEDICAL | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P950037/S229) | Biotronik, Inc. | 2025-04-15 |
| Home Monitoring System Version 3.52.0 (P070008/S131) | Biotronik, Inc. | 2025-04-15 |
| Harmony TPV System (P200046/S040) | Medtronic, Inc. | 2025-04-14 |
| HeartMate II Left Ventricular Assist System (P060040/S117) | ABBOTT MEDICAL | 2025-04-14 |
| Diamondback 360 Coronary Orbital Atherectomy System, Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S046) | Cardiovascular Systems, Inc. | 2025-04-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S103) | ABBOTT MEDICAL | 2025-04-14 |
| Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P (P030005/S245) | Guidant Corp. | 2025-04-11 |
| Essentio SR; Essentio DR; Essentio EL DR; Proponent SR; Proponent DR; Proponent EL DR; Accolade SR; Accolade DR; Accolad (N970003/S299) | Boston Scientific Corp | 2025-04-11 |
| WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (P240028) | EBR Systems, Inc. | 2025-04-11 |
| Coseal Surgical Sealant (P030039/S030) | Baxter Bio Science | 2025-04-11 |
| Preveleak Surgical Sealant 4mL; Preveleak Delivery Tips 10 PK (P100030/S020) | Baxter Healthcare Corporation | 2025-04-11 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S018) | ABBOTT MEDICAL | 2025-04-11 |
| Essentio MRI SR; Essentio MRI DR; L131 Essentio MRI EL DR; Proponent; Accolade MRI SR; Accolade MRI DR; Accolade MRI EL (P150012/S166) | Boston Scientific | 2025-04-11 |
| Inogen CRT-D; Inogen X4 CRT-D; Dynagen CRT-D; Dynagen X4 CRT-D (P010012/S589) | Boston Scientific Corp | 2025-04-11 |
| Abre Venous Self-expanding Stent System (P200026/S013) | Medtronic Vascular, Inc. | 2025-04-11 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S015) | W. L. Gore & Associates, Inc. | 2025-04-11 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S051) | Biotronik AG | 2025-04-11 |
| D010 INOGEN MINI ICD VR; D011 INOGEN MINI ICD VR; D012 INOGEN MINI ICD DR; D013 INOGEN MINI ICD DR; D020 DYNAGEN MI (P960040/S504) | Boston Scientific | 2025-04-11 |
| Safire TX Ablation Catheter; Safire TX, Catheter Extension Cable; Therapy 8mm Tip Thermistor Ablation Catheter; Therapy (P040042/S057) | Irvine Biomedical,Inc.(Ibi) | 2025-04-10 |
| PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis (P860057/S220) | Edwards Lifesciences, LLC | 2025-04-10 |
| FlexAbility Ablation Catheter; FlexAbility Ablation Catheter, Sensor Enabled (P110016/S088) | ABBOTT MEDICAL | 2025-04-10 |
| Therapy Ablation Catheter (4mm Tip Thermistor and Bi-Directional); Cables (P040014/S050) | Irvine Biomedical, Inc. | 2025-04-10 |
| Safire Bi-Directional Ablation Catheter; Safire Catheter Extension Cable (P960016/S092) | St Jude Medical | 2025-04-10 |
| TactiFlex Ablation Catheter, Sensor Enabled (P220013/S017) | ABBOTT MEDICAL | 2025-04-10 |
| Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S012) | Medtronic, Inc. | 2025-04-10 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S093) | St Jude Medical | 2025-04-10 |
| S.M.A.R.T.; S.M.A.R.T. CONTROL Vascular Stent Systems; S.M.A.R.T. RADIANZ Vascular Stent System (P120002/S029) | Cordis US Corporation | 2025-04-09 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S098) | W. L. Gore & Associates, Inc. | 2025-04-09 |
| S.M.A.R.T. CONTROL Nitinol Stent System; S.M.A.R.T. RADIANZ Vascular Stent System (P020036/S054) | Cordis US Corporation | 2025-04-09 |
| ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM (P020018/S065) | Cook, Inc. | 2025-04-09 |
| Thoraflex Hybrid (P210006/S012) | Vascutek, Ltd. | 2025-04-09 |
| INCRAFT AAA Stent Graft System (P150002/S011) | Cordis US Corporation | 2025-04-09 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S053) | Biotronik AG | 2025-04-09 |
| Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T (P130021/S176) | Medtronic, Inc. | 2025-04-08 |
| OPTIMIZER Smart System (P180036/S039) | Impulse Dynamics (Usa), Inc. | 2025-04-08 |
| QDOT MICRO System (P210027/S012) | Biosense Webster, Inc. | 2025-04-08 |
| Harmony Transcatheter Pulmonic Valve (TPV) System (P200046/S039) | Medtronic, Inc. | 2025-04-07 |
| CoreValve EnVeo Pro Delivery Catheter System; CoreValve EnVeo Pro Loading System; Evolut PRO+ Delivery Catheter System; (P130021/S175) | Medtronic, Inc. | 2025-04-07 |
| Symplicity Spyral Renal Denervation Catheter (P220026/S011) | Medtronic, Inc. | 2025-04-07 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S071) | Medtronic Vascular | 2025-04-07 |
| Harmony Delivery Catheter System (P200046/S038) | Medtronic, Inc. | 2025-04-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S102) | ABBOTT MEDICAL | 2025-04-07 |
| Endurant Stent Graft System; Endurant II Stent Graft System; Endurant II Stent AUI Graft System; Endurant IIs Stent Graf (P100021/S128) | Medtronic Vascular | 2025-04-07 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System RX and OTW; Onyx Frontier Zotarolimus Eluting Coronary Stent Sys (P160043/S087) | Medtronic Vascular | 2025-04-07 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S035) | Spectranetics Corp. | 2025-04-04 |
| PRECISE PRO RX Transcarotid Stent System (P030047/S049) | Cordis US Corporation | 2025-04-04 |
| Renamic Neo (P050023/S192) | Biotronik, Inc. | 2025-04-03 |
| Renamic Neo (P000009/S118) | Biotronik, Inc. | 2025-04-03 |
| Aurora EV-ICD (P220012/S047) | Medtronic, Inc. | 2025-04-03 |
| SYNERGY XD and SYNERGY MEGATRON Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S108) | Boston Scientific Corporation | 2025-04-03 |
| Renamic Neo (P070008/S164) | Biotronik, Inc. | 2025-04-03 |
| Aveir VR Leadless System (P150035/S022) | ABBOTT MEDICAL | 2025-04-03 |
| Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M (P980016/S921) | Medtronic Cardiac Rhythm Disease Management | 2025-04-03 |
| LIFEPAK 1000 DEFIBRILLATOR, LIFEPAK 20 DEFIBRILLATOR/ MONITOR, LIFEPAK 20E DEFIBRILLATOR/ MONITOR, LIFEPAK 15 MONITOR/DE (P160026/S057) | Physio-Control, Inc. | 2025-04-03 |
| Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P (P010015/S560) | Medtronic, Inc. | 2025-04-03 |
| FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable, (P230030/S011) | Farapulse, Inc. | 2025-04-03 |
| Renamic Neo (P950037/S269) | Biotronik, Inc. | 2025-04-03 |
| 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/S809) | Medtronic, Inc. | 2025-04-03 |
| 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/S887) | Medtronic Cardiac Rhythm Disease Management | 2025-04-03 |
| Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1 Brava CRT-D DTBC1D4 Brava Q (P010031/S886) | Medtronic Cardiac Rhythm Disease Management | 2025-04-02 |
| Aurora EV ICD DVEA3E4 (P220012/S046) | Medtronic, Inc. | 2025-04-02 |
| Cobalt MRI ICD DVPB3D4 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1 Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4 Cobalt XT MR (P980016/S920) | Medtronic Cardiac Rhythm Disease Management | 2025-04-02 |
| HeartWare HVAD System (P100047/S224) | Medtronic | 2025-04-02 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S198) | ABBOTT MEDICAL | 2025-04-01 |
| Sprint Quattro Lead (P920015/S298) | Medtronic, Inc. | 2025-04-01 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent (P910023/S461) | ABBOTT MEDICAL | 2025-04-01 |
| SelectSecure Lead (P030036/S152) | Medtronic Cardiac Rhythm Disease Management | 2025-04-01 |
| PERCEVAL SUTURELESS HEART VALVE (P150011/S032) | Corcym S.r.l. | 2025-04-01 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S084) | ABBOTT MEDICAL | 2025-04-01 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S416) | ABBOTT MEDICAL | 2025-04-01 |
| Microny family of Pacemakers (P970013/S094) | ABBOTT MEDICAL | 2025-04-01 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S333) | ABBOTT MEDICAL | 2025-04-01 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN) (P920047/S136) | Boston Scientific Corp | 2025-03-31 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro);RHYTHMIA HDx (P150005/S087) | Boston Scientific Corp | 2025-03-31 |
| RHYTHMIA HDx Ablation Connection Box (for INTELLAGEN); Rhythmia HDx Ablation Connection Box (Maestro) (P020025/S145) | Boston Scientific | 2025-03-31 |
| Thoraflex Hybrid (P210006/S010) | Vascutek, Ltd. | 2025-03-28 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S107) | W. L. Gore & Associates, Inc. | 2025-03-28 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S168) | W. L. Gore & Associates, Inc. | 2025-03-28 |
| STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR (P990071/S066) | Biosense Webster, Inc. | 2025-03-28 |
| 7F FREEZOR CARDIAC CRYOABLATION CATHETER AND CCT.2 CRYOCONSOLE SYSTEM (P020045/S112) | Medtronic Cryocath, LP | 2025-03-27 |
| MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM (P150033/S203) | Medtronic, Inc. | 2025-03-27 |
| MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) (P140017/S030) | Medtronic, Inc. | 2025-03-27 |
| ARCTIC FRONT CRYOCATHETER SYSTEM (P100010/S150) | Medtronic Cryocath, LP | 2025-03-27 |
| OPTIMIZER Smart, OPTIMIZER Smart Mini, OPTIMIZER Lite (P180036/S033) | Impulse Dynamics (Usa), Inc. | 2025-03-27 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S011) | ABBOTT MEDICAL | 2025-03-27 |
| Amplatzer Septal Occluder; Amplatzer Amulet Left Atrial Appendage Occluder (P000039/S082) | ABBOTT MEDICAL | 2025-03-27 |
| VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (P240006/S004) | Biosense Webster, Inc. | 2025-03-26 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S036) | Medtronic Vascular, Inc. | 2025-03-26 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S087) | Medtronic, Inc. | 2025-03-26 |
| Crimper (P140031/S185) | Edwards Lifesciences, LLC | 2025-03-25 |
| Paradise Ultrasound Renal Denervation System; Paradise Catheter (P220023/S008) | Recor Medical, Inc. | 2025-03-25 |
| Crimper (P200015/S062) | Edwards Lifesciences, LLC | 2025-03-25 |
| Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S013) | Medtronic, Inc. | 2025-03-21 |
| Boston Scientific Cardiac Cryoablation System (P220032/S010) | Boston Scientific Corporation | 2025-03-21 |
| Medtronic Selectsecure Lead Model 3830 (P030036/S151) | Medtronic Cardiac Rhythm Disease Management | 2025-03-20 |
| Lava Liquid Embolic System (Lava LES) and Lava Mixing Kit (P220020/S004) | Sirtex Medical, Inc. | 2025-03-20 |