| Ilivia Neo 7 VR-T DX, Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Intica Neo 7 VR-T, Intica Neo 5 VR-T DX, Intica Neo 5 VR- (P980023/S125) | Biotronik, Inc. | 2024-04-19 |
| Ilivia 7 VR-T DX, Intica 7 VR-T DX, Intica 5 VR-T DX, Ilivia 7 VR-T, Ilivia 7 VR-T, Intica 7 VR-T, Intica 7 DF4 VR-T, In (P050023/S182) | Biotronik, Inc. | 2024-04-19 |
| Medtronic Evolut FX+ Transcatheter Aortic Valve, Evolut FX Delivery Catheter System, Evolut FX Loading System (P130021/S161) | Medtronic, Inc. | 2024-04-19 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S016) | Great Batch Medical | 2024-04-19 |
| GORE® CARDIOFORM ASD Occluder (P050006/S110) | W. L. Gore & Associates, Inc. | 2024-04-18 |
| Berlin Heart EXCOR Pediatric Ventricular Assist Device (P160035/S039) | Berlin Heart, Inc. | 2024-04-18 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S067) | Boston Scientific Corp | 2024-04-18 |
| RelayPro Stent-Graft System (P200045/S011) | Bolton Medical, Inc. | 2024-04-17 |
| Impella RP and Impella RP with SmartAssist (P170011/S053) | Abiomed, Inc. | 2024-04-17 |
| RelayPlus Thoracic Stent-Graft System (P110038/S031) | Bolton Medical, Inc. | 2024-04-17 |
| TREO Abdominal Stent-Graft System (P190015/S017) | Bolton Medical, Inc. | 2024-04-17 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S259) | Medtronic, Inc. | 2024-04-16 |
| WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device with Delivery System, WATCHMAN FLX Pro Left Atrial Appendage Cl (P130013/S065) | Boston Scientific Corp | 2024-04-16 |
| Epsila EV Extravascular Lead (P220012/S022) | Medtronic, Inc. | 2024-04-16 |
| Micra AV TPS, Micra TPS (P150033/S187) | Medtronic, Inc. | 2024-04-16 |
| HeartMate 3 Left Ventricular Assist System (P160054/S077) | ABBOTT MEDICAL | 2024-04-16 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S183) | Medtronic, Inc. | 2024-04-16 |
| Y Adaptor/Extender Kit, Sprint Quattro Lead (P920015/S285) | Medtronic, Inc. | 2024-04-16 |
| HeartMate II Left Ventricular Assist System (P060040/S103) | ABBOTT MEDICAL | 2024-04-16 |
| HV Splitter, Sprint Quattro Lead (P920015/S286) | Medtronic, Inc. | 2024-04-16 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S222) | Medtronic Cardiac Rhythm Disease Management | 2024-04-16 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S015) | Edwards Lifesciences, LLC | 2024-04-15 |
| MynxGrip Vascular Closure Device (5F, 6F/7F), Mynx Control Vascular Closure Device (5F, 6F/7F) (P040044/S101) | Cordis US Corporation | 2024-04-12 |
| OPTIMIZER Smart System (P180036/S027) | Impulse Dynamics (Usa), Inc. | 2024-04-12 |
| LIFEPAK® 35 Monitor/Defibrillator (P160026/S040) | Physio-Control, Inc. | 2024-04-12 |
| AGENT Paclitaxel-Coated Balloon Catheter (P230035/S001) | Boston Scientific Corporation | 2024-04-11 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System-RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent Sys (P160043/S079) | Medtronic Vascular | 2024-04-11 |
| EluNIR-PERL Ridaforolimus Eluting Coronary Stent System (P170008/S048) | Medinol, Ltd. | 2024-04-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S062) | Medtronic Vascular | 2024-04-10 |
| Medtronic CoreValve Evolut R System (P130021/S160) | Medtronic, Inc. | 2024-04-10 |
| Aurora EV-ICD System (P220012/S019) | Medtronic, Inc. | 2024-04-10 |
| Medtronic CoreValve Evolut PRO System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs (P100021/S120) | Medtronic Vascular | 2024-04-10 |
| CareLink SmartSync (P890003/S465) | Medtronic, Inc. | 2024-04-10 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System - RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S080) | Medtronic Vascular | 2024-04-10 |
| Symplicity Spyral Renal Denervation System (P220026/S006) | Medtronic, Inc. | 2024-04-10 |
| Carbomedics Prosthetic Heart Valve (P900060/S066) | Corcym S.r.l. | 2024-04-09 |
| MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System (P100009/S064) | ABBOTT MEDICAL | 2024-04-09 |
| 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/S779) | Medtronic, Inc. | 2024-04-08 |
| SelectSecure Lead (P030036/S146) | Medtronic Cardiac Rhythm Disease Management | 2024-04-08 |
| Visi-Pro Balloon-Expandable Peripheral Stent System, lntraStent DoubleStrut Stent (P030045/S009) | Medtronic Vascular, Inc. | 2024-04-05 |
| BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLATIP MIFI XP Cable, (P020025/S139) | Boston Scientific | 2024-04-05 |
| Abre Venous Self-expanding Stent System (P200026/S008) | Medtronic Vascular, Inc. | 2024-04-05 |
| Protégé RX Carotid Stent System, tégé GPS Self-Expanding Peripheral Stent System (P060001/S040) | Medtronic Vascular, Inc. | 2024-04-05 |
| BLAZER OI Catheter Cable, INTELLATIP MIFI OI Cable, INTELLANAV Ablation Catheter Cable (P150005/S077) | Boston Scientific Corp | 2024-04-05 |
| GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S014) | W. L. Gore and Associates, Inc. | 2024-04-05 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S044) | Medtronic Vascular, Inc. | 2024-04-05 |
| A209 SICD Gen 2, A219 SICD MRI (P110042/S194) | Boston Scientific Corporation | 2024-04-05 |
| BLAZER Solid-Tip Ablation Catheter Cable 10, BLAZER Solid-Tip Ablation Catheter Cable 3, INTELLANAV Ablation Cathet (P920047/S131) | Boston Scientific Corp | 2024-04-05 |
| Amplia MRI CRT-D,Amplia MRI Quad CRTD, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Cobalt MRI (P010031/S852) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| Aurora EV ICD (P980016/S886) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| 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 (P220012/S017) | Medtronic, Inc. | 2024-04-04 |
| EVOQUE Tricuspid Valve Replacement System (P230013/S002) | Edwards Lifesciences, LLC | 2024-04-04 |
| CapSure Sense Lead (P830061/S221) | Medtronic Cardiac Rhythm Disease Management | 2024-04-04 |
| Aveir VR Delivery Catheter, Aveir DR Delivery Catheter (P150035/S009) | ABBOTT MEDICAL | 2024-04-04 |
| CapSureFix Novus Lead (P930039/S258) | Medtronic, Inc. | 2024-04-04 |
| Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology (P810002/S121) | ABBOTT MEDICAL | 2024-04-03 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S196) | W. L. Gore & Associates, Inc. | 2024-04-03 |
| 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/S777) | Medtronic, Inc. | 2024-04-02 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S043) | W. L. Gore & Associates, Inc. | 2024-04-02 |
| CardioMEMS Hospital System, model CM3100 (P100045/S074) | ABBOTT MEDICAL | 2024-04-02 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S076) | ABBOTT MEDICAL | 2024-04-01 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S102) | ABBOTT MEDICAL | 2024-04-01 |
| HeartSine's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (P160008/S024) | Heartsine Technologies, Ltd. | 2024-04-01 |
| TriClip G4 System (P230007) | ABBOTT MEDICAL | 2024-04-01 |
| 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/S778) | Medtronic, Inc. | 2024-03-30 |
| 7F Freezor Cardiac Cryoablation Catheter, 7F Freezor Xtra Cardiac Cryoablation Catheter (P020045/S109) | Medtronic Cryocath, LP | 2024-03-29 |
| Aveir VR Leadless Pacemaker: Aveir Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadle (P150035/S008) | ABBOTT MEDICAL | 2024-03-29 |
| Arctic Front Advanced Cardiac Cryoablation Catheter, Arctic Front Advanced PRO Cardiac Cryoablation Catheter, 9F Freezor (P100010/S145) | Medtronic Cryocath, LP | 2024-03-29 |
| Lead Repair Kit Model 6946 (P910073/S177) | Boston Scientific | 2024-03-28 |
| Carotid WALLSTENT Monorail Endoprosthesis (P050019/S041) | Boston Scientific Corp | 2024-03-27 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S042) | W. L. Gore & Associates, Inc. | 2024-03-27 |
| Accent, Assurity, Assurity+, Endurity, Endurity Core, Zenex, Zenus (P880086/S335) | ABBOTT MEDICAL | 2024-03-27 |
| Anthem,Allure, Allure Quadra, Quadra Allure (MRI Conditional),Quadra Allure MP (P030035/S200) | ABBOTT MEDICAL | 2024-03-27 |
| Assurity MRI, Endurity MRI,Zenex MRI (P140033/S087) | ABBOTT MEDICAL | 2024-03-27 |
| Artic Front Cryocatheter System (P100010/S146) | Medtronic Cryocath, LP | 2024-03-26 |
| Tendril STS, UltiPace (P960013/S124) | ABBOTT MEDICAL | 2024-03-26 |
| Shockwave C2/C2+ Intravascular Lithotripsy (IVL) Catheter (P200039/S014) | Shockwave Medical, Inc. | 2024-03-26 |
| Assurity MRI, Endurity MRI (P140033/S085) | ABBOTT MEDICAL | 2024-03-26 |
| ENROUTE Transcarotid Stent System (P140026/S029) | Boston Scientific Corporation | 2024-03-26 |
| Orsiro Mission Sirolimus Eluting Coronary Stent System (P170030/S036) | Biotronik AG | 2024-03-26 |
| PRO-Kinetic Energy Coronary Stent System (P160003/S019) | Biotronik AG | 2024-03-26 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S032) | Medtronic, Inc. | 2024-03-26 |
| Blazer and IntellaNav/MiFi Open-Irrigated Ablation Catheters (P150005/S083) | Boston Scientific Corp | 2024-03-25 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S053) | Edwards Lifesciences, LLC | 2024-03-25 |
| QDOT Micro Navigation Catheter (P210027/S007) | Biosense Webster, Inc. | 2024-03-25 |
| EDWARDS INTUITY Elite Valve System (P150036/S074) | Edwards Lifesciences, LLC | 2024-03-25 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S171) | Edwards Lifesciences, LLC | 2024-03-25 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S217) | Edwards Lifesciences, LLC | 2024-03-25 |
| QDOT MICRO System (P210027/S006) | Biosense Webster, Inc. | 2024-03-25 |
| Arctic Front Cardiac Cryoablation Catheter System (P100010/S141) | Medtronic Cryocath, LP | 2024-03-25 |
| Harmony TPV System (P200046/S031) | Medtronic, Inc. | 2024-03-22 |
| Ranger Paclitaxel-Coated Balloon Catheter (P190019/S029) | Boston Scientific Corporation | 2024-03-22 |
| GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (P230023/S001) | W. L. Gore & Associates, Inc. | 2024-03-22 |
| Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS (P130021/S155) | Medtronic, Inc. | 2024-03-22 |
| Navitor Transcatheter Aortic Valve, Navitor Loading System , FlexNav Delivery System, Navitor Titan Transcatheter A (P190023/S018) | ABBOTT MEDICAL | 2024-03-21 |
| HeartWare® HVAD System (P100047/S216) | Medtronic | 2024-03-21 |
| Mynx Control Vascular Closure Device (5F, 6F/7F), MynxGrip Vascular Closure Device (5F, 6F/7F) (P040044/S100) | Cordis US Corporation | 2024-03-21 |
| THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (P060040/S101) | ABBOTT MEDICAL | 2024-03-21 |
| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, (P130021/S159) | Medtronic, Inc. | 2024-03-21 |
| GORE® CARDIOFORM ASD Occluder (P050006/S107) | W. L. Gore & Associates, Inc. | 2024-03-20 |