| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S028) | Boston Scientific Corporation | 2024-03-19 |
| Cryo Cable (P220032/S003) | Boston Scientific Corporation | 2024-03-18 |
| TVL(TM) Lead System (P950022/S145) | ABBOTT MEDICAL | 2024-03-18 |
| Rotablator and ROTAPRO Rotational Atherectomy System (P900056/S216) | Boston Scientific Corp | 2024-03-15 |
| BioMimics 3D Vascular Stent System (P180003/S008) | Veryan Medical, Ltd. | 2024-03-15 |
| EVOQUE Transcatheter Tricuspid Delivery System, EVOQUE Dilator Kit, EVOQUE Loading System (P230013/S001) | Edwards Lifesciences, LLC | 2024-03-15 |
| Synergy Ablation System (P100046/S018) | AtriCure, Inc. | 2024-03-15 |
| Epic Vascular Self-Expanding Stent System (P110035/S072) | Boston Scientific Corp | 2024-03-13 |
| Wallstent ILIAC RP Endoprosthesis (P940019/S065) | Boston Scientific Scimed, Inc. | 2024-03-13 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S065) | Boston Scientific Corporation | 2024-03-13 |
| Rotablator Rotational Atherectomy System (P900056/S215) | Boston Scientific Corp | 2024-03-13 |
| Farapulse Pulsed Field Ablation System (P230030/S001) | Farapulse, Inc. | 2024-03-13 |
| Express LD Iliac Premounted Stent System (P090003/S056) | Boston Scientific Corporation | 2024-03-13 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S075) | Boston Scientific Corp | 2024-03-13 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S079) | Boston Scientific Corporation | 2024-03-13 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S091) | Boston Scientific Corp | 2024-03-13 |
| Metriq Tubing Set and Metriq Footswitch (P150005/S082) | Boston Scientific Corp | 2024-03-12 |
| 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/S882) | Medtronic Cardiac Rhythm Disease Management | 2024-03-11 |
| Alto Abdominal Stent Graft System (P120006/S039) | Endologix, LLC | 2024-03-11 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S534) | Medtronic, Inc. | 2024-03-11 |
| 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, Cobalt (P010031/S848) | Medtronic Cardiac Rhythm Disease Management | 2024-03-11 |
| 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/S775) | Medtronic, Inc. | 2024-03-11 |
| Aurora EV ICD (P220012/S015) | Medtronic, Inc. | 2024-03-11 |
| Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR2/AV2 Transcatheter Pacing System (P150033/S184) | Medtronic, Inc. | 2024-03-08 |
| Diamond Temp Catheter (P200028/S023) | Medtronic, Inc. | 2024-03-08 |
| Resolute Onyx Rapid Exchange Zotarolimus- Eluting Coronary Stent System, Resolute Onyx Over The Wire Zotarolimus- Elutin (P160043/S078) | Medtronic Vascular | 2024-03-08 |
| Harmony Transcatheter Pulmonary Valve (P200046/S029) | Medtronic, Inc. | 2024-03-08 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S157) | Medtronic, Inc. | 2024-03-08 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S040) | Boston Scientific Corp | 2024-03-08 |
| Melody Transcatheter Pulmonary Valve (P140017/S029) | Medtronic, Inc. | 2024-03-08 |
| Harmony Delivery Catheter System (P200046/S030) | Medtronic, Inc. | 2024-03-08 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst (P130021/S158) | Medtronic, Inc. | 2024-03-08 |
| Ranger-Over-The-Wire Paclitaxel Coated Balloon Catheter (P190019/S027) | Boston Scientific Corporation | 2024-03-07 |
| 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 (P980035/S776) | Medtronic, Inc. | 2024-03-06 |
| Aurora EV ICD (P220012/S016) | Medtronic, Inc. | 2024-03-06 |
| MANTA Vascular Closure Device, 14F, MANTA Vascular Closure Device, 18F, MANTA 8F Depth Locator, MANTA 14F Depth Locator (P180025/S011) | Teleflex Medical, LLC | 2024-03-06 |
| MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S099) | Cordis US Corporation | 2024-03-06 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sol (P010015/S535) | Medtronic, Inc. | 2024-03-06 |
| 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/S851) | Medtronic Cardiac Rhythm Disease Management | 2024-03-06 |
| 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/S885) | Medtronic Cardiac Rhythm Disease Management | 2024-03-06 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S774) | Medtronic, Inc. | 2024-03-06 |
| Aveir Delivery Catheter (P150035/S006) | ABBOTT MEDICAL | 2024-03-06 |
| TRIDYNE Vascular Sealant (P150016/S024) | Neomend, Inc. | 2024-03-05 |
| On-X Prosthetic Heart Valve (P000037/S062) | On-X Life Technologies, Inc. | 2024-03-05 |
| Cobalt MRI CRT-D, CobaltXT MRI CRT-D, Crome MRI CRT-D (P010031/S849) | Medtronic Cardiac Rhythm Disease Management | 2024-03-04 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S883) | Medtronic Cardiac Rhythm Disease Management | 2024-03-04 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S089) | Syncardia Systems, LLC | 2024-03-04 |
| MITRIS RESILIA Mitral Valve (P150048/S079) | Edwards Lifesciences, LLC | 2024-03-01 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S850) | Medtronic Cardiac Rhythm Disease Management | 2024-03-01 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S884) | Medtronic Cardiac Rhythm Disease Management | 2024-03-01 |
| 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 (P010031/S846) | Medtronic Cardiac Rhythm Disease Management | 2024-02-29 |
| Consulta CRT-P, Syncra CRT-P (P010015/S532) | Medtronic, Inc. | 2024-02-29 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035) | Boston Scientific Corporation | 2024-02-29 |
| Symplicity Spyral Multi-Electrode Renal Denervation Catheter (P220026/S004) | Medtronic, Inc. | 2024-02-29 |
| Aurora EV ICD (P220012/S013) | Medtronic, Inc. | 2024-02-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S069) | ABBOTT MEDICAL | 2024-02-29 |
| 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/S880) | Medtronic Cardiac Rhythm Disease Management | 2024-02-29 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S772) | Medtronic, Inc. | 2024-02-29 |
| Surmodics SurVeil Drug-Coated Balloon (P210025/S002) | Surmodics,Inc. | 2024-02-29 |
| HeartMate 3 Left Ventricular Assist System (P160054/S075) | ABBOTT MEDICAL | 2024-02-29 |
| HeartMate II Left Ventricular Assist System (P060040/S100) | ABBOTT MEDICAL | 2024-02-29 |
| Endurity, Assurity, Endurity Core, Zenus, Zenex (P880086/S332) | ABBOTT MEDICAL | 2024-02-28 |
| Symplicity Spyral Multi Electrode Renal Denervation Catheter (P220026/S003) | Medtronic, Inc. | 2024-02-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S164) | W. L. Gore & Associates, Inc. | 2024-02-28 |
| Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI (P140033/S083) | ABBOTT MEDICAL | 2024-02-28 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S103) | W. L. Gore & Associates, Inc. | 2024-02-28 |
| LIFEPAK® 1000 Defibrillator, LIFEPAK® 15 Monitor/Defibrillator (P160026/S046) | Physio-Control, Inc. | 2024-02-27 |
| External Paulse Generator (EPG) Patient Cable (P820003/S143) | Medtronic Cardiac Rhythm Disease Management | 2024-02-27 |
| RelayPro Thoracic Stent-Graft System (P200045/S010) | Bolton Medical, Inc. | 2024-02-26 |
| INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System (P150005/S074) | Boston Scientific Corp | 2024-02-26 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S073) | ABBOTT MEDICAL | 2024-02-22 |
| HeartStart HS1 Onsite Defibrillator (M5066A), HeartStart HS1 Home Defibrillator (M5068A) (P160029/S024) | Philips Medical Systems, Inc. | 2024-02-21 |
| TREO® Abdominal Stent-Graft System (P190015/S014) | Bolton Medical, Inc. | 2024-02-21 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S072) | ABBOTT MEDICAL | 2024-02-21 |
| Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura (P030054/S417) | ABBOTT MEDICAL | 2024-02-21 |
| RelayPlus Thoracic Stent-Graft System (P110038/S030) | Bolton Medical, Inc. | 2024-02-21 |
| RelayPro Thoracic Stent-Graft System (P200045/S009) | Bolton Medical, Inc. | 2024-02-21 |
| HeartSines Samaritan® Public Access Automated External Defibrillators (P160008/S023) | Heartsine Technologies, Ltd. | 2024-02-21 |
| HeartStart FRx Defibrillator (861304) (P180028/S014) | Philips Medical Systems | 2024-02-21 |
| Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify (P910023/S462) | ABBOTT MEDICAL | 2024-02-21 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S064) | Boston Scientific Scimed, Inc. | 2024-02-20 |
| Wallstent TIPS Endoprosthesis with Unistep Plus Delivery System (P930031/S074) | Boston Scientific Corp | 2024-02-20 |
| Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S064) | Boston Scientific Corporation | 2024-02-20 |
| SmartAblate Irrigation Tubing Set (P990071/S059) | Biosense Webster, Inc. | 2024-02-19 |
| INTELLANAV MIFI Open-Irrigated Ablation Catheters (P150005/S081) | Boston Scientific Corp | 2024-02-16 |
| 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/S879) | Medtronic Cardiac Rhythm Disease Management | 2024-02-16 |
| SmartAblate Irrigation Tubing Set (SAT001) (P990071/S058) | Biosense Webster, Inc. | 2024-02-16 |
| IntellaNav XP and IntellaNav MiFi XP Ablation Catheters (P020025/S143) | Boston Scientific | 2024-02-16 |
| 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/S845) | Medtronic Cardiac Rhythm Disease Management | 2024-02-16 |
| BioMimics 3D Vascular Stent System (P180003/S007) | Veryan Medical, Ltd. | 2024-02-16 |
| Aurora EV ICD (P220012/S012) | Medtronic, Inc. | 2024-02-16 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S132) | Abbott Vascular | 2024-02-15 |
| Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator (P220026/S001) | Medtronic, Inc. | 2024-02-15 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S773) | Medtronic, Inc. | 2024-02-14 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S066) | Boston Scientific Corp | 2024-02-14 |
| Consulta CRT-P, Syncra CRT-P (P010015/S533) | Medtronic, Inc. | 2024-02-14 |
| AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating (P050018/S034) | Spectranetics Corp. | 2024-02-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P140031/S170) | Edwards Lifesciences, LLC | 2024-02-14 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S041) | Berlin Heart, Inc. | 2024-02-14 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV (P200015/S052) | Edwards Lifesciences, LLC | 2024-02-14 |