| Impella Ventricular Support Systems (P140003/S107) | Abiomed, Inc. | 2023-03-29 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S214) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| CapSure SP Novus Lead, Vitatron Impulse II Lead (P850089/S164) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| SelectSecure Lead (P030036/S142) | Medtronic Cardiac Rhythm Disease Management | 2023-03-28 |
| Epic Max Tissue Heart Valves (P040021/S052) | ABBOTT MEDICAL | 2023-03-28 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S117) | ABBOTT MEDICAL | 2023-03-28 |
| Amplatzer Piccolo Occluder (P020024/S067) | ABBOTT MEDICAL | 2023-03-27 |
| Pedi-padz Multifunction Electrodes, Pro-padz Cardiology W/LVP Gel Electrodes, Pro-padz Radiolucent Liquid Gel Electrodes (P160022/S033) | ZOLL Medical Corporation | 2023-03-24 |
| 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/S816) | Medtronic Cardiac Rhythm Disease Management | 2023-03-24 |
| RangerOver-The-Wire Paclitaxel-Coated PTA Balloon Catheter (P190019/S011) | Boston Scientific Corporation | 2023-03-24 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, (P980016/S851) | Medtronic Cardiac Rhythm Disease Management | 2023-03-24 |
| AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp (P100046/S015) | AtriCure, Inc. | 2023-03-23 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent Systems, Onyx Frontier Zotarolimus-Eluting Coronary Stent Systems (P160043/S065) | Medtronic Vascular | 2023-03-23 |
| Powerheart G5 AED (P160033/S009) | ZOLL Medical Corporation | 2023-03-23 |
| Edwards Commander Delivery System (P140031/S153) | Edwards Lifesciences, LLC | 2023-03-22 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System (P170030/S023) | Biotronik AG | 2023-03-22 |
| Edwards Commander Delivery System (P200015/S035) | Edwards Lifesciences, LLC | 2023-03-22 |
| Micra AV TPS, Micra TPS (P150033/S153) | Medtronic, Inc. | 2023-03-22 |
| iCast Covered Stent System (P120003) | Atrium Medical Corp. | 2023-03-22 |
| Shockwave Intravascular Lithotripsy (IVL) System (Shockwave IVL System) with Shockwave C2 and C2+ IVL Catheters (P200039/S010) | Shockwave Medical, Inc. | 2023-03-22 |
| Epic Vascular Self-Expanding Stent System (P110035/S069) | Boston Scientific Corp | 2023-03-21 |
| Medtronic Evolut PRO+ System and Medtronic Evolut FX System (P130021/S132) | Medtronic, Inc. | 2023-03-21 |
| HeartMate II Left Ventricular Assist System (P060040/S090) | ABBOTT MEDICAL | 2023-03-21 |
| OPTIMIZER Smart Mini System (P180036/S016) | Impulse Dynamics (Usa), Inc. | 2023-03-21 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S020) | The Spectranetics Corp. | 2023-03-21 |
| Eluvia Drug Eluting Vascular Stent System (P180011/S054) | Boston Scientific Corp | 2023-03-21 |
| Innova Self-Expanding Stent System (P140028/S077) | Boston Scientific Corporation | 2023-03-21 |
| ELCA Coronary Atherectomy Catheters (P910001/S118) | Spectranetics Corp. | 2023-03-21 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S043) | Medinol, Ltd. | 2023-03-20 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S113) | Medtronic Vascular | 2023-03-17 |
| Attain Stability Quad MRI Surescan (P080006/S175) | Medtronic, Inc. | 2023-03-17 |
| Valiant Thoracic Stent Graft with Captivia Delivery System (P100040/S056) | Medtronic Vascular | 2023-03-17 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S158) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S008) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S157) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Zilver® PTX® Peripheral Drug-Eluting Stent (P100022/S041) | Cook Ireland, Ltd. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S096) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S037) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| Zilver® Vascular Stent (P050017/S021) | Cook Ireland, Ltd. | 2023-03-16 |
| Zilver Vena® Venous Self-Expanding Stent (P200023/S004) | Cook Ireland, Ltd. | 2023-03-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S097) | W. L. Gore & Associates, Inc. | 2023-03-16 |
| PROMUS ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S208) | Boston Scientific Corp | 2023-03-15 |
| SYNERGY and SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S091) | Boston Scientific Corporation | 2023-03-15 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S849) | Medtronic Cardiac Rhythm Disease Management | 2023-03-14 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S815) | Medtronic Cardiac Rhythm Disease Management | 2023-03-14 |
| Telemetry Wand (P110042/S179) | Boston Scientific Corporation | 2023-03-14 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S011) | W. L. Gore and Associates, Inc. | 2023-03-14 |
| DiamondTemp Ablation System (P200028/S016) | Medtronic, Inc. | 2023-03-13 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent Systems (P150003/S092) | Boston Scientific Corporation | 2023-03-10 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S135) | Boston Scientific Corp | 2023-03-10 |
| Promus Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S209) | Boston Scientific Corp | 2023-03-10 |
| Thermocool Smarttouch Bi-directional Catheter, Thermocool Smarttouch Bi-directional Catheter (P040036/S093) | Biosense Webster, Inc. | 2023-03-10 |
| Carotid WALLSTENT Monorail Endoprosthesis System (P050019/S037) | Boston Scientific Corp | 2023-03-10 |
| Thermocool Smarttouch SF Uni-directional Catheter, Thermocool Smarttouch SF Uni-directional Catheter (P030031/S131) | Biosense Webster, Inc. | 2023-03-10 |
| Edwards Commander Delivery System (P140031/S143) | Edwards Lifesciences, LLC | 2023-03-09 |
| CapSureFix MRI Lead (P090013/S326) | Medtronic, Inc. | 2023-03-09 |
| Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR (P980035/S742) | Medtronic, Inc. | 2023-03-09 |
| CapSureFix Novus Lead (P930039/S249) | Medtronic, Inc. | 2023-03-09 |
| TherOx Downstream System (P170027/S008) | Zoll Circulation, Inc. | 2023-03-09 |
| Edwards Commander Delivery System (P200015/S026) | Edwards Lifesciences, LLC | 2023-03-09 |
| Pulse Generator, Pacemaker, Implantable, with Cardiac Resynchronization (CRT-P) (P070008/S145) | Biotronik, Inc. | 2023-03-09 |
| Pulse Generator, Permanent, Implantable (P950037/S245) | Biotronik, Inc. | 2023-03-09 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S136) | Boston Scientific Corp | 2023-03-09 |
| HeartWare Ventricular Assist System (P100047/S206) | Medtronic | 2023-03-08 |
| Express SD Renal Monorail Premounted Stent System (P060006/S106) | Boston Scientific Corp | 2023-03-08 |
| Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (P140031/S152) | Edwards Lifesciences, LLC | 2023-03-08 |
| Express LD Iliac Premounted Stent System (P090003/S055) | Boston Scientific Corporation | 2023-03-08 |
| GORE® TAG® Thoracic Endoprosthesis, GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (P040043/S134) | W. L. Gore & Associates, Inc. | 2023-03-08 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S843) | Medtronic Cardiac Rhythm Disease Management | 2023-03-07 |
| RelayPro Thoracic Stent-Graft System (P200045/S002) | Bolton Medical, Inc. | 2023-03-07 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S048) | ABBOTT MEDICAL | 2023-03-07 |
| Arctic Front Advance (P100010/S137) | Medtronic Cryocath, LP | 2023-03-06 |
| Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Siroiimus Eiuting Coronary Stent System (P170030/S027) | Biotronik AG | 2023-03-03 |
| Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent (P200015/S034) | Edwards Lifesciences, LLC | 2023-03-03 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S006) | Edwards Lifesciences, LLC | 2023-03-03 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S016) | Biotronik AG | 2023-03-03 |
| Pioneer 2.0 HVAD Controller (P100047/S208) | Medtronic | 2023-03-03 |
| CentriMag Circulatory Support System (P170038/S011) | Abbott | 2023-03-03 |
| Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graft System (P100021/S112) | Medtronic Vascular | 2023-03-02 |
| Visi-Pro Balloon-expandable Peripheral Stent System (P030045/S007) | Medtronic Vascular, Inc. | 2023-03-02 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Elite Everolimus-Eluting Platinum Chro (P110010/S207) | Boston Scientific Corp | 2023-03-02 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY XD Everolimus-Eluting Platinum Chromium Coro (P150003/S090) | Boston Scientific Corporation | 2023-03-02 |
| Perceval S Sutureless Heart Valve; Perceval Plus Sutureless Heart Valve (P150011/S027) | Corcym S.r.l. | 2023-03-02 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S075) | Boston Scientific Corp | 2023-03-02 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S018) | Boston Scientific Corporation | 2023-03-02 |
| Wolverine Coronary Cutting Balloon (P950020/S133) | Boston Scientific Corp | 2023-03-02 |
| Express SD Renal Monorail Premounted Stent System (P060006/S105) | Boston Scientific Corp | 2023-03-02 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S042) | Medinol, Ltd. | 2023-03-01 |
| Vascade Vascular Closure System (VCS) (P120016/S029) | Cardiva Medical, Inc. | 2023-03-01 |
| Micra AV TPS (P150033/S165) | Medtronic, Inc. | 2023-03-01 |
| DiamondTemp Ablation System (P200028/S015) | Medtronic, Inc. | 2023-03-01 |
| INGEVITY and INGEVITY+ (P150012/S141) | Boston Scientific | 2023-03-01 |
| Manual Retraction Kit (P100010/S136) | Medtronic Cryocath, LP | 2023-02-28 |
| QDOT MICRO System, nGEN Generator (P210027/S001) | Biosense Webster, Inc. | 2023-02-24 |
| FlexAbility Ablation Catheter, Sensor Enabled (P110016/S082) | ABBOTT MEDICAL | 2023-02-24 |
| HeartLight Catheter, HeartLight X3 Console V2 (P150026/S014) | Cardiofocus, Inc. | 2023-02-24 |
| Organ Care System (OCS) Heart (P180051/S002) | TransMedics, Inc. | 2023-02-23 |
| Coseal Surgical Sealant, Coseal Spray Set (P030039/S028) | Baxter Bio Science | 2023-02-23 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S844) | Medtronic Cardiac Rhythm Disease Management | 2023-02-23 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S810) | Medtronic Cardiac Rhythm Disease Management | 2023-02-23 |