| Myocardial Pacing Lead (P120017/S034) | Medtronic, Inc. | 2023-11-03 |
| SelectSecure Lead (P030036/S145) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| EV ICD Aurora (P220012/S001) | Medtronic, Inc. | 2023-11-02 |
| Gore Excluder Conformable AAA Endoprosthesis(EXCC) (P200030/S015) | W. L. Gore and Associates, Inc. | 2023-11-02 |
| LIFEPAK® 15 Defibrillator Lithium- ion Rechargeable Battery Accessory (P160026/S045) | Physio-Control, Inc. | 2023-11-02 |
| PALMAZ MULLINS XD Pulmonary Stent (P220004/S001) | Cordis US Corp | 2023-11-02 |
| 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/S835) | Medtronic Cardiac Rhythm Disease Management | 2023-11-02 |
| Sentus ProMRI OTW QP S-75, Sentus ProMRI OTW QP S-85, Sentus ProMRI OTW QP S-95, Sentus ProMRI OTW QP L-75, Sentus ProMR (P070008/S155) | Biotronik, Inc. | 2023-11-02 |
| Pamira S 60, Pamira S 65, Pamira S 75, Pamira SD 60/16, Pamira SD 65/16, Pamira SD 65/18, Pamira SD 75/18, Pamira S DX 6 (P980023/S123) | Biotronik, Inc. | 2023-11-02 |
| Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I (P980016/S869) | Medtronic Cardiac Rhythm Disease Management | 2023-11-02 |
| Harmony Transcatheter Pulmonary Valve (P200046/S025) | Medtronic, Inc. | 2023-11-01 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni (P130021/S149) | Medtronic, Inc. | 2023-11-01 |
| Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni (P130021/S148) | Medtronic, Inc. | 2023-11-01 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW (P160043/S074) | Medtronic Vascular | 2023-11-01 |
| Harmony Transcatheter Pulmonary Valve (P200046/S024) | Medtronic, Inc. | 2023-11-01 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S088) | Syncardia Systems, LLC | 2023-11-01 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S059) | Boston Scientific Corp | 2023-10-31 |
| Cordis® EXOSEAL® Vascular Closure Device (P100013/S028) | Cordis US Corporation | 2023-10-31 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura (P910023/S458) | ABBOTT MEDICAL | 2023-10-31 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S413) | ABBOTT MEDICAL | 2023-10-31 |
| INSPIRIS RESILIA Aortic Valve (P150048/S075) | Edwards Lifesciences, LLC | 2023-10-31 |
| Edwards Commander Delivery System (P140031/S165) | Edwards Lifesciences, LLC | 2023-10-30 |
| Edwards Commander Delivery System (P200015/S047) | Edwards Lifesciences, LLC | 2023-10-30 |
| Philips Laser System (P910001/S121) | Spectranetics Corp. | 2023-10-30 |
| FLEXATOME CUTTING BALLOON (P950020/S141) | Boston Scientific Corp | 2023-10-30 |
| GORE® CARDIOFORM Septal Occluder (P050006/S108) | W. L. Gore & Associates, Inc. | 2023-10-30 |
| Hancock Modified Orifice Valved Conduit (P790007/S065) | Medtronic Heart Valves | 2023-10-27 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S061) | ABBOTT MEDICAL | 2023-10-27 |
| 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/S153) | Biotronik, Inc. | 2023-10-27 |
| Freestyle Bioprosthesis (P970031/S071) | Medtronic, Inc. | 2023-10-27 |
| Hancock Valved Conduit (P870078/S050) | Medtronic, Inc. | 2023-10-27 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S128) | Abbott Vascular | 2023-10-27 |
| Avalus Bioprosthesis (P170006/S028) | Medtronic, Inc. | 2023-10-27 |
| Hancock II Bioprosthesis (P980043/S077) | Medtronic, Inc. | 2023-10-27 |
| MitraClip G4 Clip Delivery System (P100009/S060) | ABBOTT MEDICAL | 2023-10-27 |
| CardioMEMSTM HF System (P100045/S070) | ABBOTT MEDICAL | 2023-10-27 |
| Mosaic Bioprosthesis (P990064/S086) | Medtronic, Inc. | 2023-10-27 |
| LAVA® Liquid Embolic System (LAVA LES) (P220020/S001) | Sirtex Medical, Inc. | 2023-10-26 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S008) | Medtronic Vascular, Inc. | 2023-10-26 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S088) | St Jude Medical | 2023-10-26 |
| FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled (P110016/S086) | ABBOTT MEDICAL | 2023-10-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S034) | Biotronik AG | 2023-10-26 |
| Livewire TC XLS Ablation Catheter, Livewire TC XLS Bi-Directional Ablation Catheter, Livewire TC Catheter Extension (P960016/S091) | St Jude Medical | 2023-10-26 |
| TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment, (P220013/S008) | ABBOTT MEDICAL | 2023-10-26 |
| Tunneling Tool (P920015/S277) | Medtronic, Inc. | 2023-10-26 |
| ASSURE Wearable Cardioverter Defibrillator System (ASSURE system) (P200037/S010) | Kestra Medical Technologies, Inc. | 2023-10-25 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S063) | ABBOTT MEDICAL | 2023-10-25 |
| LIFEPAK® CR2 defibrillator (P170018/S017) | Physio-Control, Inc. | 2023-10-25 |
| Lead Repair Kit Model 6946 (P910073/S174) | Boston Scientific | 2023-10-24 |
| DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS), DIAMONDBACK 360 Precision Coronary Orbital Atherectomy System (P130005/S039) | Cardiovascular Systems, Inc. | 2023-10-24 |
| HeartMate II Left Ventricular Assist System (P060040/S094) | ABBOTT MEDICAL | 2023-10-24 |
| Evity 8 F-T QP, Evity 8 HF-T, Enticos 8 HF-T QP, Enticos 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Edora 8 HF-T QP, Edora (P070008/S154) | Biotronik, Inc. | 2023-10-24 |
| TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) (P220013/S010) | ABBOTT MEDICAL | 2023-10-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S062) | ABBOTT MEDICAL | 2023-10-24 |
| 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/S254) | Biotronik, Inc. | 2023-10-24 |
| Barostim System Heart Failure (P180050/S010) | Cvrx, Inc. | 2023-10-23 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S152) | Biotronik, Inc. | 2023-10-23 |
| Pulse Generator, Permanent, Implantable (P950037/S253) | Biotronik, Inc. | 2023-10-23 |
| OPTIMIZER Smart Mini Implantable Pulse Generation (IPG) (P180036/S020) | Impulse Dynamics (Usa), Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp (P050023/S178) | Biotronik, Inc. | 2023-10-23 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S122) | Biotronik, Inc. | 2023-10-23 |
| Defibrillator, implantable, dual-chamber (P000009/S106) | Biotronik, Inc. | 2023-10-23 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S037) | Medinol, Ltd. | 2023-10-20 |
| HeartMate II Left Ventricular Assist System (P060040/S093) | ABBOTT MEDICAL | 2023-10-20 |
| TherOx Downstream System (P170027/S007) | Zoll Circulation, Inc. | 2023-10-20 |
| Aurora EV-ICD System (P220012) | Medtronic, Inc. | 2023-10-20 |
| BioGlue® Surgical Adhesive (P010003/S041) | Cryolife, Inc. | 2023-10-20 |
| HeartMate 3 Left Ventricular Assist System (P160054/S060) | ABBOTT MEDICAL | 2023-10-20 |
| Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy (MADIT-CRT) (P010012/S570) | Boston Scientific Corp | 2023-10-19 |
| AngioSculpt® Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S033) | Spectranetics Corp. | 2023-10-19 |
| Micra AV TPS, Micra TPS (P150033/S179) | Medtronic, Inc. | 2023-10-19 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S289) | Boston Scientific Corp | 2023-10-18 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S234) | Guidant Corp. | 2023-10-18 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S013) | Edwards Lifesciences, LLC | 2023-10-18 |
| SICD Gen 2, SICD MRI (P110042/S190) | Boston Scientific Corporation | 2023-10-18 |
| 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/S760) | Medtronic, Inc. | 2023-10-18 |
| SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, SJM Masters Series Aortic Valved Graft (P810002/S120) | ABBOTT MEDICAL | 2023-10-18 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S152) | Boston Scientific | 2023-10-18 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S525) | Medtronic, Inc. | 2023-10-18 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S497) | Boston Scientific | 2023-10-18 |
| HeartWare HVAD System (P100047/S214) | Medtronic | 2023-10-18 |
| Epic Supra Valve, Epic Valve, Epic Plus Stented Tissue Valve, Epic Plus Supra Valve, Epic Max Valve (P040021/S053) | ABBOTT MEDICAL | 2023-10-18 |
| LIFEPAK® 15 monitor/defibrillator (P160026/S043) | Physio-Control, Inc. | 2023-10-18 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S576) | Boston Scientific Corp | 2023-10-18 |
| iCast Covered Stent System (P120003/S003) | Atrium Medical Corp. | 2023-10-18 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S087) | Syncardia Systems, LLC | 2023-10-18 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S178) | Medtronic, Inc. | 2023-10-18 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S059) | ABBOTT MEDICAL | 2023-10-17 |
| MynxGrip and Mynx Control Vascular Closure Device (P040044/S095) | Cordis US Corporation | 2023-10-17 |
| SYNERGY SHIELD Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chrom (P150003/S098) | Boston Scientific Corporation | 2023-10-17 |
| ENROUTE® Transcarotid Stent System (P140026/S028) | Boston Scientific Corporation | 2023-10-16 |
| TactiFlex SE Ablation Catheter, Sensor Enabled (P220013/S009) | ABBOTT MEDICAL | 2023-10-13 |
| INGEVITY and INGEVITY+TM active leads (P150012/S150) | Boston Scientific | 2023-10-13 |
| TREO Abdominal Stent-Graft System (P190015/S012) | Bolton Medical, Inc. | 2023-10-12 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated (P140010/S076) | Medtronic, Inc. | 2023-10-12 |
| RelayPlus Thoracic Stent-Graft System (P110038/S029) | Bolton Medical, Inc. | 2023-10-12 |
| RelayPro Thoracic Stent-Graft System (P200045/S008) | Bolton Medical, Inc. | 2023-10-12 |
| LimFlow System (P220025/S001) | LimFlow, Inc. | 2023-10-12 |
| MitraClip G4 Delivery System (P100009/S058) | ABBOTT MEDICAL | 2023-10-12 |
| Harmony Delivery Catheter System (P200046/S022) | Medtronic, Inc. | 2023-10-12 |