| SJM Masters Series Mechanical Heart Valve, 15mm HP (P810002/S119) | ABBOTT MEDICAL | 2023-12-04 |
| WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System (P130013/S063) | Boston Scientific Corp | 2023-12-04 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S459) | ABBOTT MEDICAL | 2023-12-01 |
| 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/S765) | Medtronic, Inc. | 2023-12-01 |
| Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF (P030054/S414) | ABBOTT MEDICAL | 2023-12-01 |
| OPTIhome Remote Patient Monitoring System (P180036/S024) | Impulse Dynamics (Usa), Inc. | 2023-12-01 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S062) | ABBOTT MEDICAL | 2023-12-01 |
| Harmony Transcatheter Pulmonary Valve (P200046/S026) | Medtronic, Inc. | 2023-11-30 |
| Freezer MAX (P100010/S143) | Medtronic Cryocath, LP | 2023-11-29 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRTP, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar (P010015/S528) | Medtronic, Inc. | 2023-11-29 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0/LD, Impella 5.5 with SmartAssist (P140003/S115) | Abiomed, Inc. | 2023-11-29 |
| Lead EV ICD Extravascular - Epsila (P220012/S007) | Medtronic, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P220013/S001) | ABBOTT MEDICAL | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P040042/S055) | Irvine Biomedical,Inc.(Ibi) | 2023-11-29 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI, Compia MRI CRT-D, (P010031/S838) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| 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/S874) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P040014/S048) | Irvine Biomedical, Inc. | 2023-11-29 |
| 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,Ev (P980016/S872) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| Aurora EV ICD (P220012/S006) | Medtronic, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P960016/S090) | St Jude Medical | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P110016/S084) | ABBOTT MEDICAL | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P030054/S412) | ABBOTT MEDICAL | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P950022/S144) | ABBOTT MEDICAL | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P060019/S055) | Irvine Biomedical, Inc. | 2023-11-29 |
| HV Splitter/Adaptor kit, Sprint Quattro Lead (P920015/S284) | Medtronic, Inc. | 2023-11-29 |
| Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion (P910023/S457) | ABBOTT MEDICAL | 2023-11-29 |
| 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/S766) | Medtronic, Inc. | 2023-11-29 |
| Preveleak Surgical Sealant, Preveleak I 0-pack delivery tips (P100030/S018) | Baxter Healthcare Corporation | 2023-11-29 |
| 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/S840) | Medtronic Cardiac Rhythm Disease Management | 2023-11-29 |
| Freezer, Freezer Xtra (P020045/S106) | Medtronic Cryocath, LP | 2023-11-29 |
| EV ICD - Aurora (P220012/S004) | Medtronic, Inc. | 2023-11-29 |
| Ampere Generator, Ampere Remote Control, Ampere Generator System Kit (P130026/S086) | St Jude Medical | 2023-11-29 |
| Freestyle Bioprosthesis (P970031/S072) | Medtronic, Inc. | 2023-11-28 |
| Fourier-Transform Infrared Spectroscopy (FTIR) (P010012/S578) | Boston Scientific Corp | 2023-11-28 |
| Hancock II Bioprosthesis (P980043/S078) | Medtronic, Inc. | 2023-11-28 |
| Mosaic Bioprosthesis (P990064/S087) | Medtronic, Inc. | 2023-11-28 |
| Avalus Bioprosthesis (P170006/S030) | Medtronic, Inc. | 2023-11-28 |
| Tendril STS, UltiPace (P960013/S123) | ABBOTT MEDICAL | 2023-11-28 |
| LifeVest® Wearable Defibrillator (P010030/S172) | Zoll Manufacturing Corporation | 2023-11-27 |
| DIAMONDBACK 360® Coronary Orbital Atherectomy System (OAS) (P130005/S041) | Cardiovascular Systems, Inc. | 2023-11-27 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S026) | Boston Scientific Corporation | 2023-11-24 |
| EPi-Sense Guided Coagulation System (P200002/S007) | AtriCure, Inc. | 2023-11-22 |
| Synergy Ablation System (P100046/S017) | AtriCure, Inc. | 2023-11-22 |
| MOMENTUM CRT-D, MOMENTUM, MOMENTUM X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, DYNAGEN CRT-D, DYNAGEN X4 CRT-D, VIGIL (P010012/S577) | Boston Scientific Corp | 2023-11-21 |
| INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD DR, MOMENTUM EL ICD VR, MOMENTUM EL (P960040/S498) | Boston Scientific | 2023-11-21 |
| MISAGO® RX Self-expanding Peripheral Stent (P140002/S027) | Terumo Medical Corporation | 2023-11-21 |
| SICD Gen 2, SICD MRI (P110042/S191) | Boston Scientific Corporation | 2023-11-21 |
| XIENCE Sierra Everolimus Eluting Coronary Stent System (XIENCE Sierra), XIENCE Skypoint Everolimus Eluting Coronary Sten (P110019/S129) | Abbott Vascular | 2023-11-21 |
| LifeVest Wearable Defibrillator Models 4000 and 5100 (P010030/S171) | Zoll Manufacturing Corporation | 2023-11-21 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S046) | Medinol, Ltd. | 2023-11-21 |
| Protégé GPS Self-Expanding Peripheral Stent System (P060001/S038) | Medtronic Vascular, Inc. | 2023-11-21 |
| EverFlex Self-Expanding Peripheral Stent System (P110023/S041) | Medtronic Vascular, Inc. | 2023-11-21 |
| 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/S762) | Medtronic, Inc. | 2023-11-20 |
| Thoraflex Hybrid (P210006/S005) | Vascutek, Ltd. | 2023-11-20 |
| Edwards Commander Delivery System (P140031/S166) | Edwards Lifesciences, LLC | 2023-11-20 |
| 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/S870) | Medtronic Cardiac Rhythm Disease Management | 2023-11-20 |
| 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/S836) | Medtronic Cardiac Rhythm Disease Management | 2023-11-20 |
| MitraClip G4 Clip Delivery System (P100009/S055) | ABBOTT MEDICAL | 2023-11-20 |
| Edwards Commander Delivery System (P200015/S048) | Edwards Lifesciences, LLC | 2023-11-20 |
| EV ICD - Aurora (P220012/S002) | Medtronic, Inc. | 2023-11-20 |
| POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories (P220032/S001) | Boston Scientific Corporation | 2023-11-17 |
| Symplicity Spyral Renal Denervation System (P220026) | Medtronic, Inc. | 2023-11-17 |
| Attain Performa Lead (P080006/S180) | Medtronic, Inc. | 2023-11-17 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (P210032/S012) | W. L. Gore & Associates, Inc. | 2023-11-17 |
| HeartMate II Left Ventricular Assist System (P060040/S095) | ABBOTT MEDICAL | 2023-11-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S065) | ABBOTT MEDICAL | 2023-11-16 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S039) | W. L. Gore & Associates, Inc. | 2023-11-15 |
| HeartStart Onsite Defibrillator (M5066A), HeartStart Home Defibrillator (M5068A),HeartStart HS1 SMART Pads, Adult (M5071 (P160029/S021) | Philips Medical Systems, Inc. | 2023-11-15 |
| HeartLogic (P010012/S571) | Boston Scientific Corp | 2023-11-15 |
| EPIC Self Expanding Stent System (P110035/S071) | Boston Scientific Corp | 2023-11-15 |
| Innova Vascular Self-Expanding Stent System (P140028/S078) | Boston Scientific Corporation | 2023-11-15 |
| HeartLogic (P960040/S493) | Boston Scientific | 2023-11-15 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S058) | Boston Scientific Corp | 2023-11-15 |
| HV Splitter/Adaptor kit (P920015/S281) | Medtronic, Inc. | 2023-11-13 |
| samaritan® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr (P160008/S022) | Heartsine Technologies, Ltd. | 2023-11-13 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S014) | Edwards Lifesciences, LLC | 2023-11-13 |
| Alto Abdominal Stent Graft System (P120006/S043) | Endologix, LLC | 2023-11-09 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S062) | Boston Scientific Corp | 2023-11-09 |
| 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/S763) | Medtronic, Inc. | 2023-11-08 |
| Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S181) | Medtronic, Inc. | 2023-11-08 |
| On-X Prosthetic Heart Valve and Ascending Aortic Prothesis (P000037/S061) | On-X Life Technologies, Inc. | 2023-11-08 |
| Lava Liquid Embolic System (Lava LES) (P220020/S002) | Sirtex Medical, Inc. | 2023-11-07 |
| Open Pivot heart valve (P990046/S069) | Medtronic Ats Medical, Inc. | 2023-11-07 |
| Paradise® Ultrasound Renal Denervation System (P220023) | Recor Medical, Inc. | 2023-11-07 |
| PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves (P190023/S016) | ABBOTT MEDICAL | 2023-11-07 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter (P130021/S150) | Medtronic, Inc. | 2023-11-07 |
| CapSure Sense Lead (P830061/S219) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S526) | Medtronic, Inc. | 2023-11-03 |
| CapSure VDD-2 Lead (P890003/S464) | Medtronic, Inc. | 2023-11-03 |
| 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/S868) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| Transvene CS/SVC Lead (P980050/S142) | Medtronic, Inc. | 2023-11-03 |
| Attain StarFix Lead (P060039/S115) | Medtronic, Inc. | 2023-11-03 |
| CapSure Epicardial Pacing Lead (P950024/S109) | Medtronic, Inc. | 2023-11-03 |
| Harmony TPV System (P200046/S023) | Medtronic, Inc. | 2023-11-03 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S179) | Medtronic, Inc. | 2023-11-03 |
| Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MRI (P980035/S761) | Medtronic, Inc. | 2023-11-03 |
| Epicardial Patch Lead (P900061/S172) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |
| CapSureFix Lead, CapSureFix Novus Lead (P930039/S255) | Medtronic, Inc. | 2023-11-03 |
| Sprint Quattro Lead, Subcutaneous Lead (P920015/S282) | Medtronic, Inc. | 2023-11-03 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, (P010031/S834) | Medtronic Cardiac Rhythm Disease Management | 2023-11-03 |