| Perclose ProStyle Suture-Mediated Closure and Repair System, Perclose ProGlide Suture-Mediated Closure System (P960043/S118) | Abbott Vascular, Inc. | 2023-06-02 |
| EverFlex Self-Expanding Peripheral Stent System, EverFlex Self-Expanding Peripheral Stent with Entrust Delivery Syste (P110023/S037) | Medtronic Vascular, Inc. | 2023-06-02 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System RX and OTW, Onyx Frontier Zotarolimus-Eluting Coronary Stent S (P160043/S069) | Medtronic Vascular | 2023-06-02 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant II AUI Stent Graft System, Endurant IIs Stent Graf (P100021/S115) | Medtronic Vascular | 2023-06-02 |
| CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath (P130021/S138) | Medtronic, Inc. | 2023-06-02 |
| Edwards Commander delivery system (Size 29mm) (P140031/S157) | Edwards Lifesciences, LLC | 2023-06-02 |
| Diamondback 360 Precision Coronary Orbital Atherectomy System (P130005/S036) | Cardiovascular Systems, Inc. | 2023-06-01 |
| Artic Front Advanced Cardiac Cryoablation Catheter, Artic Front Advanced PRO Cardiac Cryoablation Catheter (P100010/S138) | Medtronic Cryocath, LP | 2023-06-01 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S011) | Edwards Lifesciences, LLC | 2023-06-01 |
| LifeVest® Wearable Defibrillator (P010030/S164) | Zoll Manufacturing Corporation | 2023-05-31 |
| PASCAL Precision Transcatheter Valve Repair System (Implant System), PASCAL Precision Transcatheter Valve Repair System (P220003/S009) | Edwards Lifesciences, LLC | 2023-05-31 |
| CryoConsole (P020045/S104) | Medtronic Cryocath, LP | 2023-05-31 |
| PASCAL Precision Transcatheter Valve Repair System (Guide Sheath), PASCAL Precision Transcatheter Valve Repair System (I (P220003/S010) | Edwards Lifesciences, LLC | 2023-05-30 |
| SAPIEN 3 Pulmonic Delivery System (S3 PDS) (P200015/S039) | Edwards Lifesciences, LLC | 2023-05-30 |
| Thoraflex Hybrid (P210006/S004) | Vascutek, Ltd. | 2023-05-26 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S213) | Medtronic Cardiac Rhythm Disease Management | 2023-05-26 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S250) | Medtronic, Inc. | 2023-05-26 |
| EPi-Sense ST RF Cable (P200002/S006) | AtriCure, Inc. | 2023-05-25 |
| ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) (P200037/S008) | Kestra Medical Technologies, Inc. | 2023-05-25 |
| Loctite® 4206 (P200028/S017) | Medtronic, Inc. | 2023-05-24 |
| Harmony Transcatheter Pulmonic Valve System (P200046/S016) | Medtronic, Inc. | 2023-05-23 |
| CapSureFix Novus Lead (P930039/S251) | Medtronic, Inc. | 2023-05-23 |
| Endurity MRI, Assurity MRI (P140033/S080) | ABBOTT MEDICAL | 2023-05-23 |
| 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/S746) | Medtronic, Inc. | 2023-05-23 |
| Pulsar-18 T3 Stent System (P160025/S016) | Biotronik AG | 2023-05-23 |
| Accent, Accent MRI, Assurity, Assurity+, Endurity ,Endurity Core (P880086/S329) | ABBOTT MEDICAL | 2023-05-23 |
| CPR-D-padz electrode (P160015/S015) | ZOLL Medical Corporation | 2023-05-23 |
| Sterallex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S021) | The Spectranetics Corp. | 2023-05-23 |
| CapSure Sense Lead (P830061/S215) | Medtronic Cardiac Rhythm Disease Management | 2023-05-23 |
| CPR-D-padz electrode (P160022/S034) | ZOLL Medical Corporation | 2023-05-23 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S195) | ABBOTT MEDICAL | 2023-05-23 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter (P140010/S073) | Medtronic, Inc. | 2023-05-22 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S024) | Medtronic Vascular, Inc. | 2023-05-22 |
| Multifunctional Ablation Generator (MAG) (P200002/S005) | AtriCure, Inc. | 2023-05-19 |
| Multifunctional Ablation Generator (MAG) (P100046/S016) | AtriCure, Inc. | 2023-05-19 |
| TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C (P220013) | ABBOTT MEDICAL | 2023-05-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S156) | Edwards Lifesciences, LLC | 2023-05-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S038) | Edwards Lifesciences, LLC | 2023-05-18 |
| Sprint Quattro Lead (P920015/S276) | Medtronic, Inc. | 2023-05-17 |
| Programming software modules for Orchestra Plus and SmartTouch programmers, Remote monitoring software (P980049/S145) | MicroPort CRM USA, Inc. | 2023-05-17 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro (P980016/S855) | Medtronic Cardiac Rhythm Disease Management | 2023-05-17 |
| ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S133) | MicroPort CRM USA, Inc. | 2023-05-17 |
| ALIZEA and CELEA pacemakers, Remote monitoring software (RMS) (P950029/S132) | MicroPort CRM USA, Inc. | 2023-05-17 |
| 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/S821) | Medtronic Cardiac Rhythm Disease Management | 2023-05-17 |
| Programming software modules for Orchestra Plus and SmartTouch programmers, CPR4 Telemetry head accessory for SmartTouch (P980049/S144) | MicroPort CRM USA, Inc. | 2023-05-17 |
| ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers (P950029/S127) | MicroPort CRM USA, Inc. | 2023-05-17 |
| INGEVITY+ and INGEVITY MRI Pace/Sense leads (P150012/S145) | Boston Scientific | 2023-05-17 |
| VEGA Steroid-Eluting Endocardial Leads (VEGA R45, VEGA R52, and VEGA R58) (P130010) | MicroPort CRM USA, Inc. | 2023-05-17 |
| Smartview Connect remote monitoring solution (P980049/S139) | MicroPort CRM USA, Inc. | 2023-05-17 |
| OUS HeartTone MRI Application Software (P890003/S460) | Medtronic, Inc. | 2023-05-16 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S820) | Medtronic Cardiac Rhythm Disease Management | 2023-05-16 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S854) | Medtronic Cardiac Rhythm Disease Management | 2023-05-16 |
| EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) Anneal Parameters (P110042/S182) | Boston Scientific Corporation | 2023-05-12 |
| NG3 Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), NG4 CRT-Ds (P010012/S568) | Boston Scientific Corp | 2023-05-11 |
| Accolade CRT Pacemakers (CRT-Ps) (P030005/S229) | Guidant Corp. | 2023-05-11 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) (P110042/S183) | Boston Scientific Corporation | 2023-05-11 |
| PASCAL Precision Transcatheter Valve Repair System (P220003/S008) | Edwards Lifesciences, LLC | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P000009/S103) | Biotronik, Inc. | 2023-05-11 |
| Accolade MRI Pacemakers (P150012/S142) | Boston Scientific | 2023-05-11 |
| NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs (P960040/S491) | Boston Scientific | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P980023/S119) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P950037/S247) | Biotronik, Inc. | 2023-05-11 |
| WATCHMAN FLX Left Atrial Appendage Closure Device with Delivery System (P130013/S052) | Boston Scientific Corp | 2023-05-11 |
| Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads (P960013/S122) | ABBOTT MEDICAL | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P070008/S147) | Biotronik, Inc. | 2023-05-11 |
| Home Monitoring System Version 3.56.0 (P050023/S174) | Biotronik, Inc. | 2023-05-11 |
| Accolade Pacemakers (N970003/S284) | Boston Scientific Corp | 2023-05-11 |
| Rotablator and ROTAPRO Rotational Atherectomy Systems (P900056/S207) | Boston Scientific Corp | 2023-05-10 |
| Navitor Transcatheter Aortic Heart Valve (P190023/S015) | ABBOTT MEDICAL | 2023-05-10 |
| Micra AV TPS, Micra TPS, Micra VR TPS (P150033/S170) | Medtronic, Inc. | 2023-05-09 |
| Micra AV H3, Micra Scalable, Micra AV TPS, Micra VR TPS (P150033/S171) | Medtronic, Inc. | 2023-05-09 |
| Organ Care System (OCS) Heart System (P180051/S003) | TransMedics, Inc. | 2023-05-09 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S044) | Medinol, Ltd. | 2023-05-09 |
| Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter (P200039/S011) | Shockwave Medical, Inc. | 2023-05-08 |
| AFX2 Endovascular AAA System (P040002/S071) | Endologix, LLC | 2023-05-08 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, (N970003/S286) | Boston Scientific Corp | 2023-05-08 |
| Express LD Iliac Premounted Stent System (P090003/S054) | Boston Scientific Corporation | 2023-05-08 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S231) | Guidant Corp. | 2023-05-08 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL (P150012/S144) | Boston Scientific | 2023-05-08 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System, SYNERGY MEGATRON Everolimus-Eluting Platinum Chromi (P150003/S095) | Boston Scientific Corporation | 2023-05-05 |
| Wolverine Coronary Cutting Balloon (P950020/S138) | Boston Scientific Corp | 2023-05-05 |
| IN.PACT AV DCB (P190008/S023) | Medtronic Vascular, Inc. | 2023-05-04 |
| Spectranetics Laser Sheath (SLS ll/GlideLight) (P960042/S071) | Spectranetics (Philips) | 2023-05-04 |
| ECLA Coronary Atherectomy Catheters (P910001/S119) | Spectranetics Corp. | 2023-05-04 |
| IN.PACT Admiral DCB (P140010/S072) | Medtronic, Inc. | 2023-05-04 |
| Micra AV TPS, Micra VR TPS (P150033/S169) | Medtronic, Inc. | 2023-05-04 |
| EDWARDS INTUITY Elite Valve System, Delivery System (P150036/S068) | Edwards Lifesciences, LLC | 2023-05-04 |
| Micra AV TPS, Micra VR TPS (P150033/S168) | Medtronic, Inc. | 2023-05-04 |
| Thermocool Smarttouch SF (P030031/S132) | Biosense Webster, Inc. | 2023-05-03 |
| MitraClip Clip Delivery System (P100009/S054) | ABBOTT MEDICAL | 2023-05-03 |
| Thermocool Smarttouch (P040036/S094) | Biosense Webster, Inc. | 2023-05-03 |
| FlexAbility Ablation Catheter, FlexAbility SE (P110016/S083) | ABBOTT MEDICAL | 2023-05-02 |
| TactiCath SE Catheter (P130026/S085) | St Jude Medical | 2023-05-02 |
| GORE TAG Thoracic Branch Endoprosthesis (TBE Device) (P210032/S007) | W. L. Gore & Associates, Inc. | 2023-05-02 |
| Amplatzer Amulet (ACP2) (P200049/S005) | ABBOTT MEDICAL | 2023-05-02 |
| CryoConsole (P020045/S103) | Medtronic Cryocath, LP | 2023-05-02 |
| Amplatzer Septal Occluder (ASO/ASD) (P000039/S077) | ABBOTT MEDICAL | 2023-05-02 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P960040/S492) | Boston Scientific | 2023-05-01 |
| Resolute Onyx (RX), Resolute Onyx (OTW), Resolute Onyx (RX) (2.0mm), Resolute Onyx (OTW) (2.0mm), Onyx Frontier RX Zotar (P160043/S068) | Medtronic Vascular | 2023-05-01 |
| Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P150012/S143) | Boston Scientific | 2023-05-01 |