| COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT (P010012/S543) | Boston Scientific Corp | 2021-11-30 |
| QUIK-PAK Electrodes (P160012/S002) | Physio-Control, Inc. | 2021-11-29 |
| GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder (P050006/S096) | W. L. Gore & Associates, Inc. | 2021-11-29 |
| Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System (P900056/S195) | Boston Scientific Corp | 2021-11-26 |
| Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead (P080006/S166) | Medtronic, Inc. | 2021-11-24 |
| XACT Carotid Stent System (P040038/S038) | Abbott Vascular, Inc. | 2021-11-24 |
| Resolute Onyx RX Zotarolimus-Eluting Coronary Stent System, Resolute Onyx OTW Zotarolimus-Eluting Coronary Stent System (P160043/S056) | Medtronic Vascular | 2021-11-24 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S235) | Medtronic, Inc. | 2021-11-24 |
| SelectSecure Lead (P030036/S134) | Medtronic Cardiac Rhythm Disease Management | 2021-11-24 |
| HeartMate II Left Ventricular Assist System (P060040/S081) | ABBOTT MEDICAL | 2021-11-24 |
| Sprint Quattro Lead (P920015/S262) | Medtronic, Inc. | 2021-11-24 |
| CapSureFix MRI Lead (P090013/S318) | Medtronic, Inc. | 2021-11-24 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S201) | Medtronic Cardiac Rhythm Disease Management | 2021-11-24 |
| Micra AV TPS, Micra TPS (P150033/S128) | Medtronic, Inc. | 2021-11-24 |
| HeartMate 3 Left Ventricular Assist System (P160054/S040) | ABBOTT MEDICAL | 2021-11-24 |
| CardioMEMS HF System (P100045/S052) | ABBOTT MEDICAL | 2021-11-23 |
| HeartWare® Ventricular Assist System or HeartWare® System (P100047/S191) | Medtronic | 2021-11-23 |
| Fluency® Plus Endovascular Stent Graft (P130029/S011) | Bard Peripheral Vascular, Inc. | 2021-11-23 |
| E-Luminexx® Vascular Stent (P080007/S026) | Bard Peripheral Vascular, Inc. | 2021-11-23 |
| Impella CP with SmartAssist (P140003/S085) | Abiomed, Inc. | 2021-11-22 |
| HeartWare Ventricular Assist System (P100047/S183) | Medtronic | 2021-11-22 |
| Impella CP with SmartAssist System, Impella 5.5 with SmartAssist System (P140003/S089) | Abiomed, Inc. | 2021-11-22 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S005) | W. L. Gore and Associates, Inc. | 2021-11-22 |
| Impella RP (P170011/S034) | Abiomed, Inc. | 2021-11-22 |
| Micra AV TPS, Micra TPS (P150033/S126) | Medtronic, Inc. | 2021-11-22 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, Impella 5.5 with SmartAssist and Impella LD (P140003/S084) | Abiomed, Inc. | 2021-11-22 |
| Venovo Venous Stent System (P180037/S007) | Bard Peripheral Vascular, Inc. | 2021-11-19 |
| XIENCE PRIME, XIENCE PRIME LL Everolimus Eluting Coronary Stent Systems; XIENCE Xpedition, XIENCE Xpedition SV, XIENCE X (P110019/S119) | Abbott Vascular | 2021-11-19 |
| Endurant Stent Graft System; Endurant II Stent Graft System; Endurant IIS Stent Graft System (P100021/S096) | Medtronic Vascular | 2021-11-19 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S001) | Kestra Medical Technologies, Inc. | 2021-11-19 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, KONECT RESILIA AVC, Edwards INSPIRIS (P150048/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| 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/S796) | Medtronic Cardiac Rhythm Disease Management | 2021-11-18 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S015) | Edwards Lifesciences, LLC | 2021-11-18 |
| Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic Bioprosthesis with ThermaFix® tissue process, Carpentier-Edwards (P860057/S205) | Edwards Lifesciences, LLC | 2021-11-18 |
| 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/S761) | Medtronic Cardiac Rhythm Disease Management | 2021-11-18 |
| EDWARDS INTUITY Elite Valve System (P150036/S059) | Edwards Lifesciences, LLC | 2021-11-18 |
| Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter (P160049/S013) | The Spectranetics Corp. | 2021-11-18 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S023) | Berlin Heart, Inc. | 2021-11-18 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P140031/S137) | Edwards Lifesciences, LLC | 2021-11-18 |
| ResQCPR System (P110024/S003) | ZOLL Medical Corporation | 2021-11-17 |
| Arctic Front Advance®, Arctic Front Advance Pro® Cardiac CryoAblation Catheters (P100010/S121) | Medtronic Cryocath, LP | 2021-11-17 |
| Integrity Coronary Stent System Rx and OTW (P030009/S106) | Medtronic, Ireland | 2021-11-16 |
| EMBLEM S-ICD pulse generator (PG) Models A209/A219 (P110042/S161) | Boston Scientific Corporation | 2021-11-16 |
| RelayPro Thoracic Stent-Graft System (P200045/S001) | Bolton Medical, Inc. | 2021-11-16 |
| Resolute Integrity RX Zotarolimus-Eluting Coronary Stent System (P110013/S115) | Medtronic Vascular | 2021-11-16 |
| Amplatzer Amulet Left Atrial Appendage Occluder (P200049/S003) | ABBOTT MEDICAL | 2021-11-16 |
| GORE® CARDIOFORM ASD Occluder (P050006/S095) | W. L. Gore & Associates, Inc. | 2021-11-16 |
| HeartStart FRx Defibrillator (861304) (P180028/S011) | Philips Medical Systems | 2021-11-15 |
| Carotid Wallstent Monorail Endoprosthesis (P050019/S032) | Boston Scientific Corp | 2021-11-15 |
| Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System (P190023/S001) | ABBOTT MEDICAL | 2021-11-12 |
| GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S089) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S147) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S086) | W. L. Gore & Associates, Inc. | 2021-11-12 |
| VISITAG SURPOINT External Processing Unit (EPU) (P030031/S110) | Biosense Webster, Inc. | 2021-11-12 |
| Transvene CS/SVC Lead (P980050/S135) | Medtronic, Inc. | 2021-11-10 |
| Attain Stability Quad MRI Lead (P080006/S164) | Medtronic, Inc. | 2021-11-10 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S049) | Medtronic Vascular | 2021-11-10 |
| CapSureFix MRI Lead (P090013/S316) | Medtronic, Inc. | 2021-11-10 |
| ASSURE Wearable Cardioverter Defibrillator (WCD) System (P200037/S002) | Kestra Medical Technologies, Inc. | 2021-11-10 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S233) | Medtronic, Inc. | 2021-11-10 |
| Epicardial Patch Lead (P900061/S166) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead (P920015/S260) | Medtronic, Inc. | 2021-11-10 |
| CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead (P850089/S158) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| MynxGrip Vascular Closure Device (SF, 6F/7F) ; Mynx Control Vascular Closure Device (SF, 6F/7F) (P040044/S089) | Cordis US Corporation | 2021-11-10 |
| CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead (P830061/S199) | Medtronic Cardiac Rhythm Disease Management | 2021-11-10 |
| Arctic Front Advance Cardiac Cryoablation Catheter; Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S120) | Medtronic Cryocath, LP | 2021-11-09 |
| Abre Venous self-expanding stent system (P200026/S003) | Medtronic Vascular, Inc. | 2021-11-05 |
| Mynx Control and Mynx Grip Vascular Closure Device (P040044/S088) | Cordis US Corporation | 2021-11-05 |
| Arctic Front® Advance Cardiac Cryoablation Catheter (P100010/S119) | Medtronic Cryocath, LP | 2021-11-05 |
| LifeVest® Wearable Defibrillator (P010030/S154) | Zoll Manufacturing Corporation | 2021-11-04 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S070) | St Jude Medical | 2021-11-04 |
| Reveal LINQ Application Software (P890003/S448) | Medtronic, Inc. | 2021-11-03 |
| MynxGrip Vascular Closure Device (VCD) (P040044/S087) | Cordis US Corporation | 2021-11-03 |
| Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D (P010031/S760) | Medtronic Cardiac Rhythm Disease Management | 2021-11-03 |
| Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD (P980016/S795) | Medtronic Cardiac Rhythm Disease Management | 2021-11-03 |
| Wolverine Coronary Cutting Balloon (P950020/S112) | Boston Scientific Corp | 2021-11-02 |
| Physio-Control LIFEPAK® 20e defibrillator/monitor (P160026/S028) | Physio-Control, Inc. | 2021-11-02 |
| Zilver® PTX® Drug-Eluting Peripheral Stent (P100022/S038) | Cook Ireland, Ltd. | 2021-11-02 |
| DiamondTemp Ablation System (P200028/S002) | Medtronic, Inc. | 2021-11-02 |
| Exoseal® Vascular Closure Device (P100013/S022) | Cordis US Corporation | 2021-11-02 |
| EXCOR® Pediatric Ventricular Assist Device (P160035/S022) | Berlin Heart, Inc. | 2021-11-02 |
| Siello T/JT, Solia T/JT, Siello S, Solia S, Evia DR, Evia DR-T, Evia SR, Entovis DR, Entovis DR-T, Entovis SR, Entovis S (P950037/S230) | Biotronik, Inc. | 2021-10-29 |
| PHYLAX AV ICD SYSTEM (P980023/S109) | Biotronik, Inc. | 2021-10-29 |
| Sentus ProMRI OTW QP S, Sentus ProMRI OTW QP S-xx/49, Sentus ProMRI OTW QP L, Sentus ProMRI OTW QP Lxx/49m, Evia HF, Evi (P070008/S132) | Biotronik, Inc. | 2021-10-29 |
| Iforia 7, Ilesto 5, Iforia 5, Itrevia 7, Iperia 7, Ilivia 7, Intica 7, Intica 5, Inlexa 3, Inventra 7, Itrevia 5, Iperia (P050023/S163) | Biotronik, Inc. | 2021-10-29 |
| Edwards SAPIEN 3 transcatheter heart valve (P140031/S136) | Edwards Lifesciences, LLC | 2021-10-28 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S012) | The Spectranetics Corp. | 2021-10-28 |
| Stellarex 0.035 OTW Drug-coated Angioplasty Balloon (P160049/S010) | The Spectranetics Corp. | 2021-10-28 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (P200015/S014) | Edwards Lifesciences, LLC | 2021-10-28 |
| Perclose ProStyle Suture-Mediated Closure and Repair System (P960043/S115) | Abbott Vascular, Inc. | 2021-10-27 |
| DiamondTemp Ablation System (P200028/S007) | Medtronic, Inc. | 2021-10-27 |
| Adapta, Versa, Sensia IPG, Relia IPG (P980035/S693) | Medtronic, Inc. | 2021-10-27 |
| Coseal Surgical Sealant; Coseal Spray Set (P030039/S027) | Baxter Bio Science | 2021-10-27 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S002) | Cook Ireland, Ltd. | 2021-10-26 |
| RX Herculink Elite Renal and Biliary Stent System (P110001/S016) | Abbott Vascular | 2021-10-26 |
| Micra AV TPS; Micra TPS (P150033/S121) | Medtronic, Inc. | 2021-10-26 |
| CentriMag Circulatory Support System (P170038/S008) | Abbott | 2021-10-22 |
| GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S184) | W. L. Gore & Associates, Inc. | 2021-10-22 |
| MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW) (P100009/S044) | ABBOTT MEDICAL | 2021-10-22 |
| ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA (P150012/S119) | Boston Scientific | 2021-10-21 |