| Protego EP PASSION (P980023/S118) | Biotronik, Inc. | 2023-01-16 |
| Protego EP PASSION (P050023/S170) | Biotronik, Inc. | 2023-01-16 |
| CapSureFix Novus Lead (P930039/S248) | Medtronic, Inc. | 2023-01-16 |
| 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/S737) | Medtronic, Inc. | 2023-01-16 |
| 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/S845) | Medtronic Cardiac Rhythm Disease Management | 2023-01-13 |
| 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/S811) | Medtronic Cardiac Rhythm Disease Management | 2023-01-13 |
| Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste (P190023/S002) | ABBOTT MEDICAL | 2023-01-13 |
| CARBOMEDICS Prosthetic Heart Valve (CPHV) (P900060/S062) | Corcym S.r.l. | 2023-01-13 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P050023/S169) | Biotronik, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P000009/S100) | Biotronik, Inc. | 2023-01-12 |
| GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S132) | W. L. Gore & Associates, Inc. | 2023-01-12 |
| Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U (P070008/S143) | Biotronik, Inc. | 2023-01-12 |
| PSW 2202.U and NEO 2202.U (P950037/S242) | Biotronik, Inc. | 2023-01-12 |
| LIFEPAK® CR2 Defibrillator (P170018/S015) | Physio-Control, Inc. | 2023-01-10 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S006) | Kestra Medical Technologies, Inc. | 2023-01-10 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S050) | ABBOTT MEDICAL | 2023-01-10 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S089) | ABBOTT MEDICAL | 2023-01-10 |
| Impella2.5, ImpellaCP, Impella CP with SmartAssist (P140003/S106) | Abiomed, Inc. | 2023-01-06 |
| CardioMEMS HF System (P100045/S064) | ABBOTT MEDICAL | 2023-01-06 |
| 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/S736) | Medtronic, Inc. | 2023-01-04 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S037) | Physio-Control, Inc. | 2023-01-04 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S060) | Edwards Lifesciences, LLC | 2022-12-29 |
| EPi-Sense®, EPi-Sense ST Guided Coagulation System (P200002/S004) | AtriCure, Inc. | 2022-12-27 |
| Alto Abdominal Stent Graft System (P120006/S041) | Endologix, LLC | 2022-12-22 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S094) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S036) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S105) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S005) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S155) | W. L. Gore & Associates, Inc. | 2022-12-21 |
| MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CRT-D, RESONATE CRT- (P010012/S566) | Boston Scientific Corp | 2022-12-20 |
| ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 SR, ALTRUA 2 DR (N970003/S282) | Boston Scientific Corp | 2022-12-20 |
| ICD Devices (P960040/S483) | Boston Scientific | 2022-12-20 |
| Cordis® PALMAZ® Balloon-Expandable Stent (P890017/S023) | Cordis US Corporation | 2022-12-20 |
| PG ESSENTIO MRI SR, PG ESSENTIO MRI DR, PG PROPONENT MRI SR, PG PROPONENT MRI DR, PG ACCOLADE MRI SR, PG ACCOLADE MRI DR (P150012/S138) | Boston Scientific | 2022-12-20 |
| CRT-D Resynchronization Devices (P010012/S559) | Boston Scientific Corp | 2022-12-20 |
| Supera Peripheral Stent System Nylon Pouch (P120020/S029) | Abbott Vascular (Idef Technologies Inc) | 2022-12-20 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S005) | Edwards Lifesciences, LLC | 2022-12-20 |
| ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR (P960040/S489) | Boston Scientific | 2022-12-20 |
| Pacemaker Devices (N970003/S277) | Boston Scientific Corp | 2022-12-20 |
| Pacemaker Devices (P150012/S131) | Boston Scientific | 2022-12-20 |
| PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S227) | Guidant Corp. | 2022-12-20 |
| Subcutaneous ICD Devices (P110042/S173) | Boston Scientific Corporation | 2022-12-20 |
| CRT-P Resynchronization Devices (P030005/S222) | Guidant Corp. | 2022-12-20 |
| LATITUDE NXT Release 7.1.5 (P910077/S188) | Boston Scientific | 2022-12-20 |
| Zoll OneStep Cable, X Series Multifunction Therapy Cable, Propaq MD Multifunction Cable, X Series OneStep Cable, Multifu (P160022/S014) | ZOLL Medical Corporation | 2022-12-20 |
| Zoll R series OneStep CPR Cable, R Series Onestep Pacing Cable, R Series MFC (Multi-Function Cable), Multifunction Thera (P160022/S016) | ZOLL Medical Corporation | 2022-12-19 |
| Prostar XL Percutaneous Vascular Surgical System, Perclose ProGlide Suture-Mediated Closure System, Perclose ProStyle (P960043/S119) | Abbott Vascular, Inc. | 2022-12-16 |
| ENROUTE Transcarotid Stent System (P140026/S026) | Boston Scientific Corporation | 2022-12-16 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S117) | Biotronik, Inc. | 2022-12-16 |
| Cordis® PRECISE® Nitinol Stent Systems (P030047/S046) | Cordis US Corporation | 2022-12-16 |
| Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems, (P020036/S048) | Cordis US Corporation | 2022-12-16 |
| Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes (P950037/S243) | Biotronik, Inc. | 2022-12-16 |
| Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems (P120002/S023) | Cordis US Corporation | 2022-12-16 |
| Therapy Ablation Catheter (4mm and 8mm), Electrophysiology Cables (16, 17, 18 and 19 Series) (P040014/S047) | Irvine Biomedical, Inc. | 2022-12-16 |
| StarClose SE Vascular Closure System (P050007/S042) | Abbott Vascular Devices | 2022-12-16 |
| Safire TX Ablation Catheter, Therapy Dual-8 Ablation Catheter, Safire TX, Catheter Extension Cable (P040042/S053) | Irvine Biomedical,Inc.(Ibi) | 2022-12-16 |
| ENROUTE® Transcarotid Stent System (P140026/S025) | Boston Scientific Corporation | 2022-12-16 |
| INGEVITY+ and INGEVITY MRI (P150012/S137) | Boston Scientific | 2022-12-15 |
| MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System (P100009/S050) | ABBOTT MEDICAL | 2022-12-15 |
| TactiSys Quartz Equipment (P130026/S082) | St Jude Medical | 2022-12-15 |
| Protégé GPS Self-Expanding Peripheral Stent System, Protégé RX Carotid Stent System (P060001/S035) | Medtronic Vascular, Inc. | 2022-12-15 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S036) | Medtronic Vascular, Inc. | 2022-12-15 |
| GORE® CARDIOFORM ASD Occluder (P050006/S104) | W. L. Gore & Associates, Inc. | 2022-12-15 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S281) | Boston Scientific Corp | 2022-12-14 |
| Trifecta (P100029/S049) | ABBOTT MEDICAL | 2022-12-14 |
| SICD Gen 2, SICD MRI (P110042/S177) | Boston Scientific Corporation | 2022-12-14 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S488) | Boston Scientific | 2022-12-14 |
| Biocor/Epic (P040021/S051) | ABBOTT MEDICAL | 2022-12-14 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S080) | ABBOTT MEDICAL | 2022-12-14 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S226) | Guidant Corp. | 2022-12-14 |
| LATITUDE Wave Communicator Model 6290 (P910077/S190) | Boston Scientific | 2022-12-14 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S565) | Boston Scientific Corp | 2022-12-14 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S136) | Boston Scientific | 2022-12-14 |
| Portico (P190023/S011) | ABBOTT MEDICAL | 2022-12-14 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2+ Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S008) | Shockwave Medical, Inc. | 2022-12-13 |
| DiamondTemp Ablation System (P200028/S013) | Medtronic, Inc. | 2022-12-13 |
| MRI Pacemakers (P150012/S132) | Boston Scientific | 2022-12-12 |
| Crimper (P140031/S150) | Edwards Lifesciences, LLC | 2022-12-12 |
| Cardiac Resynchronization Therapy Defibrillator (CRT-D) (P010012/S560) | Boston Scientific Corp | 2022-12-12 |
| Micra AV TPS, Micra TPS (P150033/S164) | Medtronic, Inc. | 2022-12-12 |
| Crimper (P200015/S032) | Edwards Lifesciences, LLC | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (N970003/S280) | Boston Scientific Corp | 2022-12-12 |
| Myopore Sutureless Myocardial Pacing Lead (P130012/S010) | Great Batch Medical | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P030005/S225) | Guidant Corp. | 2022-12-12 |
| Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S223) | Guidant Corp. | 2022-12-12 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S174) | Boston Scientific Corporation | 2022-12-12 |
| Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P150012/S134) | Boston Scientific | 2022-12-12 |
| Non-MRI Pacemakers (N970003/S278) | Boston Scientific Corp | 2022-12-12 |
| LIFEPAK® 15 Monitor/Defibrillator (P160026/S036) | Physio-Control, Inc. | 2022-12-12 |
| Implantable Cardioverter Defibrillator (ICD) (P960040/S484) | Boston Scientific | 2022-12-12 |
| FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE) (P110016/S081) | ABBOTT MEDICAL | 2022-12-08 |
| Safire Ablation Catheter (P040042/S054) | Irvine Biomedical,Inc.(Ibi) | 2022-12-08 |
| Livewire TC Ablation Catheter (P960016/S089) | St Jude Medical | 2022-12-08 |
| TactiCath Ablation Catheter, Sensor Enabled (SE) (P130026/S081) | St Jude Medical | 2022-12-08 |
| Pulse Generator, Permanent, Implantable (P950037/S241) | Biotronik, Inc. | 2022-12-07 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S142) | Biotronik, Inc. | 2022-12-07 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S132) | Boston Scientific Corp | 2022-12-07 |
| Cordis® PRECISE® Nitinol Stent System (P030047/S045) | Cordis US Corporation | 2022-12-07 |
| Artic Front Advance Cardiac Cryoablation Catheter, Artic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S133) | Medtronic Cryocath, LP | 2022-12-07 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S168) | Biotronik, Inc. | 2022-12-07 |