| Transvene CS/SVC Lead (P980050/S129) | Medtronic, Inc. | 2020-11-18 |
| HeartWare Left Ventricular Assist System (P100047/S163) | Medtronic | 2020-11-18 |
| Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, and Solara Quadripolar CRT-P (P010015/S454) | Medtronic, Inc. | 2020-11-18 |
| Epicardial Patch Lead (P900061/S161) | Medtronic Cardiac Rhythm Disease Management | 2020-11-18 |
| Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, and En (P070008/S119) | Biotronik, Inc. | 2020-11-17 |
| LifeVest Wearable Defibrillator (P010030/S145) | Zoll Manufacturing Corporation | 2020-11-17 |
| Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Edora 8 (P950037/S216) | Biotronik, Inc. | 2020-11-17 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG (P980035/S655) | Medtronic, Inc. | 2020-11-16 |
| EMBLEM S-ICD Pulse Generator and EMBLEM MRI S-ICD Pulse Generator (P110042/S147) | Boston Scientific Corporation | 2020-11-16 |
| VALITUDE, VALITUDE X4, VISIONIST and VISIONIST X4 (P030005/S204) | Guidant Corp. | 2020-11-16 |
| ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S103) | Boston Scientific | 2020-11-16 |
| ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE (N970003/S258) | Boston Scientific Corp | 2020-11-16 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S012) | Biotronik AG | 2020-11-13 |
| Orsiro Sirolimus Eluting Coronary Stent System (P170030/S013) | Biotronik AG | 2020-11-13 |
| CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL (P010012/S526) | Boston Scientific Corp | 2020-11-12 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S660) | Medtronic, Inc. | 2020-11-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S002) | Boston Scientific Corporation | 2020-11-12 |
| AngioJet Rheolytic Thrombectomy System (P980037/S083) | Boston Scientific Corp | 2020-11-12 |
| VENTAK AV AICD VENTAK PRIZM DR/VR, VITALITY, COFIENT, AND TELIGEN AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR SYSTEM (P960040/S457) | Boston Scientific | 2020-11-12 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S718) | Medtronic Cardiac Rhythm Disease Management | 2020-11-11 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S757) | Medtronic Cardiac Rhythm Disease Management | 2020-11-11 |
| EDWARDS INTUITY Elite Valve (P150036/S053) | Edwards Lifesciences, LLC | 2020-11-10 |
| PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro (P860057/S200) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S112) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (Pulmonic) (P200015/S001) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards SAPIEN 3 Transcatheter Heart Valve, Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P140031/S121) | Edwards Lifesciences, LLC | 2020-11-10 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis (P150048/S050) | Edwards Lifesciences, LLC | 2020-11-10 |
| Arctic Front Advance and Arctic Front Pro Catheters Shaft Components (P100010/S109) | Medtronic Cryocath, LP | 2020-11-09 |
| LOTUS Edge Valve System (P180029/S028) | Boston Scientific Corporation | 2020-11-06 |
| Impella RP (P170011/S028) | Abiomed, Inc. | 2020-11-06 |
| Impella 2.5, Impella CP, Impelia CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S077) | Abiomed, Inc. | 2020-11-06 |
| Home Monitoring System Version 3.48 (P950037/S214) | Biotronik, Inc. | 2020-11-05 |
| ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM (P960040/S458) | Boston Scientific | 2020-11-05 |
| Home Monitoring System Version 3.48 (P070008/S117) | Biotronik, Inc. | 2020-11-05 |
| Home Monitoring System Version 3.48 (P980023/S102) | Biotronik, Inc. | 2020-11-05 |
| Edwards Commander Delivery System (P200015/S002) | Edwards Lifesciences, LLC | 2020-11-05 |
| LifeVest Wearable Defibrillator (P010030/S146) | Zoll Manufacturing Corporation | 2020-11-05 |
| Home Monitoring System Version 3.48 (P000009/S087) | Biotronik, Inc. | 2020-11-05 |
| S-ICD GEN 2 and S-ICD EMBLEM MRI (P110042/S149) | Boston Scientific Corporation | 2020-11-05 |
| Home Monitoring System Version 3.48 (P050023/S150) | Biotronik, Inc. | 2020-11-05 |
| Edwards Commander Delivery System (P140031/S122) | Edwards Lifesciences, LLC | 2020-11-05 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR (P010012/S527) | Boston Scientific Corp | 2020-11-05 |
| Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis (P990064/S082) | Medtronic, Inc. | 2020-11-03 |
| 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/S653) | Medtronic, Inc. | 2020-11-03 |
| 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/S713) | Medtronic Cardiac Rhythm Disease Management | 2020-11-02 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, (P980035/S638) | Medtronic, Inc. | 2020-11-02 |
| MyCareLink Patient Monitor (P890003/S434) | Medtronic, Inc. | 2020-11-02 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M (P980016/S752) | Medtronic Cardiac Rhythm Disease Management | 2020-11-02 |
| Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter (P960016/S084) | St Jude Medical | 2020-11-02 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S447) | Medtronic, Inc. | 2020-11-02 |
| Therapy Ablation Catheters (P040014/S040) | Irvine Biomedical, Inc. | 2020-11-02 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap (P110016/S070) | ABBOTT MEDICAL | 2020-11-02 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P040042/S046) | Irvine Biomedical,Inc.(Ibi) | 2020-11-02 |
| TactiCath Quartz Catheter and TactiSys Quartz Equipment (P130026/S062) | St Jude Medical | 2020-11-02 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation Catheters (P060019/S048) | Irvine Biomedical, Inc. | 2020-11-02 |
| Micra AV TPS and Micra TPS (P150033/S085) | Medtronic, Inc. | 2020-11-02 |
| Ranger™ Paclitaxel-Coated PTA Balloon Catheter (P190019) | Boston Scientific Corporation | 2020-10-30 |
| Talent Occluder (P100021/S085) | Medtronic Vascular | 2020-10-30 |
| ORSIRO Sirolimus Eluting Coronary Stent System (P170030/S011) | Biotronik AG | 2020-10-30 |
| Integrity Rapid Exchange Coronary Stent System (P030009/S098) | Medtronic, Ireland | 2020-10-30 |
| TREO Abdominal Stent-Graft System (P190015/S006) | Bolton Medical, Inc. | 2020-10-30 |
| EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo (P130021/S081) | Medtronic, Inc. | 2020-10-30 |
| TREO Abdominal Stent-Graft System (P190015/S003) | Bolton Medical, Inc. | 2020-10-30 |
| AngioJet Rheolytic Thrombectomy Catheter (P980037/S082) | Boston Scientific Corp | 2020-10-29 |
| Assurity, Assurity+, and Endurity (P880086/S314) | ABBOTT MEDICAL | 2020-10-29 |
| Assurity MRI and Endurity MRI (P140033/S061) | ABBOTT MEDICAL | 2020-10-29 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S657) | Medtronic, Inc. | 2020-10-28 |
| SynCardia temporary Total Artificial Heart System (P030011/S079) | Syncardia Systems, LLC | 2020-10-28 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S382) | ABBOTT MEDICAL | 2020-10-28 |
| Fortify, Fortify Assura, and Ellipse (P910023/S430) | ABBOTT MEDICAL | 2020-10-28 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S010) | Bard Peripheral Vascular, Inc. | 2020-10-28 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valv (P150048/S049) | Edwards Lifesciences, LLC | 2020-10-28 |
| 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/S651) | Medtronic, Inc. | 2020-10-28 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S453) | Medtronic, Inc. | 2020-10-28 |
| HeartMate II Left Ventricular Assist System (LVAS) (P060040/S078) | ABBOTT MEDICAL | 2020-10-27 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S018) | Berlin Heart, Inc. | 2020-10-27 |
| Edwards SAPIEN XT Transcatheter Heart Valve (P130009/S109) | Edwards Lifesciences, LLC | 2020-10-27 |
| Perclose ProStyle Suture-Mediated Closue and Repair System (P960043/S107) | Abbott Vascular, Inc. | 2020-10-27 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S116) | Edwards Lifesciences, LLC | 2020-10-27 |
| Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional) (P910023/S433) | ABBOTT MEDICAL | 2020-10-26 |
| Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) (P960013/S115) | ABBOTT MEDICAL | 2020-10-26 |
| Assurity MRI, Endurity MRI, Tendril MRI (P140033/S063) | ABBOTT MEDICAL | 2020-10-26 |
| Microny (P970013/S084) | ABBOTT MEDICAL | 2020-10-26 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL (P880086/S315) | ABBOTT MEDICAL | 2020-10-26 |
| 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/S650) | Medtronic, Inc. | 2020-10-26 |
| Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) (P950022/S136) | ABBOTT MEDICAL | 2020-10-26 |
| Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass (P030054/S386) | ABBOTT MEDICAL | 2020-10-26 |
| CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S216) | Medtronic, Inc. | 2020-10-26 |
| Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) (P030035/S182) | ABBOTT MEDICAL | 2020-10-26 |
| IsoFlex Optim (P960030/S071) | ABBOTT MEDICAL | 2020-10-26 |
| Defibtech Automated External Defibrillator (AED) Systems (P160032/S009) | Defibtech, LLC | 2020-10-23 |
| GORE CARDIOFORM Septal Occluder (P050006/S085) | W. L. Gore & Associates, Inc. | 2020-10-23 |
| Cordis S.M.A.R.T. CONTROL and S.M.A.R.T. Vascular Stent System (P120002/S018) | Cordis US Corporation | 2020-10-23 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S017) | Berlin Heart, Inc. | 2020-10-23 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S043) | Cordis US Corporation | 2020-10-23 |
| TELIGEN, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILANT, PERCIVA - ICD Device (P960040/S453) | Boston Scientific | 2020-10-22 |
| HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories (P160008/S014) | Heartsine Technologies, Ltd. | 2020-10-22 |
| EMBLEM S-ICD - Subcutaneous Devices (P110042/S142) | Boston Scientific Corporation | 2020-10-22 |
| 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/S717) | Medtronic Cardiac Rhythm Disease Management | 2020-10-22 |
| PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG (N970003/S257) | Boston Scientific Corp | 2020-10-22 |