| WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (P130013/S060) | Boston Scientific Corp | 2023-12-23 |
| Medtronic CoreValve System, Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System (P130021/S151) | Medtronic, Inc. | 2023-12-23 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S096) | ABBOTT MEDICAL | 2023-12-23 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S066) | ABBOTT MEDICAL | 2023-12-23 |
| EXOSEAL Vascular Closure Device (P100013/S027) | Cordis US Corporation | 2023-12-23 |
| Barostim System (P180050/S009) | Cvrx, Inc. | 2023-12-22 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S042) | Physio-Control, Inc. | 2023-12-22 |
| Powerheart® G5 AED (P160033/S010) | ZOLL Medical Corporation | 2023-12-21 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S028) | Biotronik AG | 2023-12-21 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella 5.5 with SmartAssist Systems (P140003/S117) | Abiomed, Inc. | 2023-12-21 |
| Impella RP, Impella RP with SmartAssist and Impella RP Flex Systems (P170011/S052) | Abiomed, Inc. | 2023-12-21 |
| HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (P160029/S020) | Philips Medical Systems, Inc. | 2023-12-19 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P040021/S055) | ABBOTT MEDICAL | 2023-12-18 |
| Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves (P190023/S017) | ABBOTT MEDICAL | 2023-12-18 |
| Coaxial Umbilical Cable - single pack, Coaxial Umbilical Cable - 12 pack (P020045/S107) | Medtronic Cryocath, LP | 2023-12-15 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S009) | Cook Medical Incorporated | 2023-12-15 |
| Xience Skypoint Everolimus Eluting Coronary Stent System (XIENCE Skypoint) , XIENCE PROs Everolimus Eluting Coronary Ste (P110019/S130) | Abbott Vascular | 2023-12-15 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S044) | Physio-Control, Inc. | 2023-12-15 |
| Aurora EV ICD (P220012/S009) | Medtronic, Inc. | 2023-12-15 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG (P980035/S768) | Medtronic, Inc. | 2023-12-15 |
| Patient Cable (P820003/S141) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| 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/S842) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| 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/S876) | Medtronic Cardiac Rhythm Disease Management | 2023-12-15 |
| Zenith® Dissection Endovascular System (P180001/S010) | William Cook Europe Aps | 2023-12-15 |
| Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S121) | Abbott Vascular, Inc. | 2023-12-14 |
| Zenith® Fenestrated AAA Endovascular Graft, Zenith® Flex AAA Endovascular System (P020018/S061) | Cook, Inc. | 2023-12-14 |
| HeartMate II Left Ventricular Assist System (P060040/S097) | ABBOTT MEDICAL | 2023-12-14 |
| HeartMate 3 Left Ventricular Assist System (P160054/S068) | ABBOTT MEDICAL | 2023-12-14 |
| DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (OAS) (P130005/S040) | Cardiovascular Systems, Inc. | 2023-12-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S051) | Edwards Lifesciences, LLC | 2023-12-14 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S038) | Berlin Heart, Inc. | 2023-12-14 |
| Zenith® Dissection Endovascular System (P180001/S008) | William Cook Europe Aps | 2023-12-14 |
| Patient Cable (P820003/S142) | Medtronic Cardiac Rhythm Disease Management | 2023-12-14 |
| Zenith Alpha Thoracic Endovascular Graft (P140016/S007) | Cook Medical Incorporated | 2023-12-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S169) | Edwards Lifesciences, LLC | 2023-12-14 |
| CapSureFix MRI Lead (P090013/S330) | Medtronic, Inc. | 2023-12-13 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S181) | Medtronic, Inc. | 2023-12-13 |
| TREO Abdominal Stent-Graft System (P190015/S013) | Bolton Medical, Inc. | 2023-12-13 |
| CapSureFix Novus Lead (P930039/S256) | Medtronic, Inc. | 2023-12-13 |
| Myocardial Pacing Lead (P120017/S035) | Medtronic, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P000009/S105) | Biotronik, Inc. | 2023-12-13 |
| CapSure Epicardial Pacing Lead (P950024/S110) | Medtronic, Inc. | 2023-12-13 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S529) | Medtronic, Inc. | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P070008/S151) | Biotronik, Inc. | 2023-12-13 |
| Aurora EV ICD (P220012/S008) | Medtronic, Inc. | 2023-12-13 |
| Zenith Alpha Thoracic Endovascular Graft (ZTA) (P140016/S008) | Cook Medical Incorporated | 2023-12-13 |
| DF-1 Connector Port Pin Plug, HV Splitter/Adopter Kit, Sprint Quattro Lead (P920015/S283) | Medtronic, Inc. | 2023-12-13 |
| Lead EV ICD Extravascular - Epsila (P220012/S005) | Medtronic, Inc. | 2023-12-13 |
| Zenith® Fenestrated AAA Endovascular Graft (ZFEN), Zenith® Flex AAA Endovascular System (P020018/S062) | Cook, Inc. | 2023-12-13 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S189) | Boston Scientific Corporation | 2023-12-13 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRT Quad CRT-D, Cobalt (P010031/S841) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| 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/S875) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P050023/S177) | Biotronik, Inc. | 2023-12-13 |
| Zenith® Dissection Endovascular System (P180001/S009) | William Cook Europe Aps | 2023-12-13 |
| 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/S839) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PSW 2303.U, NEO 2303.U (P950037/S252) | Biotronik, Inc. | 2023-12-13 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S015) | Great Batch Medical | 2023-12-13 |
| Attain Ability Lead (P080006/S182) | Medtronic, Inc. | 2023-12-13 |
| Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra (P980035/S767) | Medtronic, Inc. | 2023-12-13 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, E (P980016/S873) | Medtronic Cardiac Rhythm Disease Management | 2023-12-13 |
| PulseSelect Pulsed Field Ablation (PFA) system (P230017) | Medtronic, Inc. | 2023-12-13 |
| Blazer Open-Irrigated Ablation Catheter (P150005/S080) | Boston Scientific Corp | 2023-12-12 |
| Chilli Cooled Rf Ablation System (P980003/S097) | Boston Scientific Corp | 2023-12-12 |
| Rotablator Rotational Atherectomy System (P900056/S212) | Boston Scientific Corp | 2023-12-12 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S002) | Boston Scientific Corporation | 2023-12-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S025) | Boston Scientific Corporation | 2023-12-12 |
| WOLVERINE Coronary Cutting Balloon (P950020/S142) | Boston Scientific Corp | 2023-12-12 |
| PROMUS Element Plus and Promus PREMIER and Promus ELITE Everolimus-Eluting Stent System (P110010/S212) | Boston Scientific Corp | 2023-12-12 |
| REBEL Platinum Chromium Coronary Stent System Monorail and Over the Wire (P130030/S077) | Boston Scientific Corp | 2023-12-12 |
| ROTAPRO Rotational Atherectomy System (P900056/S213) | Boston Scientific Corp | 2023-12-12 |
| Blazer II Cardiac Ablation System and Cable (P920047/S134) | Boston Scientific Corp | 2023-12-12 |
| Express® SD Renal Monorail Premounted Stent System (P060006/S109) | Boston Scientific Corp | 2023-12-12 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S142) | Boston Scientific | 2023-12-12 |
| EDWARDS INTUITY Elite Valve (P150036/S071) | Edwards Lifesciences, LLC | 2023-12-11 |
| Carpentier-Edwards PERIMOUNT Aortic and Mitral Surgical Heart Valves (P860057/S214) | Edwards Lifesciences, LLC | 2023-12-11 |
| MynxGrip Vascular Closure Device and Mynx Control Vascular Closure Device (VCD) (P040044/S096) | Cordis US Corporation | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S167) | Edwards Lifesciences, LLC | 2023-12-11 |
| EPi-Sense Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S008) | AtriCure, Inc. | 2023-12-11 |
| LifeVest® Wearable Defibrillator (P010030/S168) | Zoll Manufacturing Corporation | 2023-12-11 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S049) | Edwards Lifesciences, LLC | 2023-12-11 |
| 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/S843) | Medtronic Cardiac Rhythm Disease Management | 2023-12-10 |
| Aurora EV ICD (P220012/S010) | Medtronic, Inc. | 2023-12-10 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI VR ICD, Mirro MRI DR ICD, (P980016/S877) | Medtronic Cardiac Rhythm Disease Management | 2023-12-10 |
| GORE® VIATORR® TIPS Endoprosthesis (P040027/S094) | W. L. Gore & Associates, Inc. | 2023-12-08 |
| EluNIR-PERLTM Ridaforolimus Eluting Coronary Stent System (P170008/S047) | Medinol, Ltd. | 2023-12-08 |
| EMBLEM S-ICD VI Electrode (Lead) (P110042/S192) | Boston Scientific Corporation | 2023-12-08 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CR T-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia (P010031/S837) | Medtronic Cardiac Rhythm Disease Management | 2023-12-07 |
| EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi (P980016/S871) | Medtronic Cardiac Rhythm Disease Management | 2023-12-07 |
| EV ICD - Aurora (P220012/S003) | Medtronic, Inc. | 2023-12-07 |
| MicraAVTPS, Miera TPS (P150033/S180) | Medtronic, Inc. | 2023-12-07 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S527) | Medtronic, Inc. | 2023-12-07 |
| Astra S DR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG,Azure S SR MRI IPG, Azure XT DR MRI IPG (P980035/S764) | Medtronic, Inc. | 2023-12-07 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S215) | Edwards Lifesciences, LLC | 2023-12-06 |
| Paradise Ultrasound Renal Denervation System (Paradise System), Paradise Cartridge (P220023/S001) | Recor Medical, Inc. | 2023-12-06 |
| Rotablatorand ROTAPRO Rotational Atherectomy System (P900056/S214) | Boston Scientific Corp | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra RES (P140031/S168) | Edwards Lifesciences, LLC | 2023-12-06 |
| EDWARDS INTUITY Elite Valve (P150036/S072) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC (P150048/S076) | Edwards Lifesciences, LLC | 2023-12-06 |
| Edwards SAPIEN 3 Transcatheter Heart Valve for Pulmonic Indication (P200015/S050) | Edwards Lifesciences, LLC | 2023-12-06 |
| Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (P160049/S022) | The Spectranetics Corp. | 2023-12-05 |