| Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, (P130021/S104) | Medtronic, Inc. | 2021-10-21 |
| VALITUDE CRT-P; VALITUDE X4 CRT-P (P030005/S214) | Guidant Corp. | 2021-10-21 |
| ORIGEN CRT-D; ORIGEN X4 CRT-D; INOGEN CRT-D; INOGEN X4 CRT-D; DYNAGEN CRT-D; DYNAGEN X4 CRT-D; AUTOGEN CRT-D; MOMENTUM C (P010012/S547) | Boston Scientific Corp | 2021-10-21 |
| ESSENTIO SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE SR; ACCOLADE DR; ACC (N970003/S269) | Boston Scientific Corp | 2021-10-21 |
| EMBLEM S-ICD; EMBLEM MRI S ICD (P110042/S165) | Boston Scientific Corporation | 2021-10-21 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR,DYNAGEN MINI ICD D (P960040/S472) | Boston Scientific | 2021-10-21 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S021) | Berlin Heart, Inc. | 2021-10-20 |
| BILEAFLET-CENTER OPENING CARDIAC VALVE (P810002/S114) | ABBOTT MEDICAL | 2021-10-20 |
| Medtronic Evolut Pro+ Transcatheter Delivery Catheter System (P130021/S105) | Medtronic, Inc. | 2021-10-19 |
| EMBLEM S-ICD PG models A209 and A219. (P110042/S160) | Boston Scientific Corporation | 2021-10-19 |
| Attain Ability Lead (P080006/S163) | Medtronic, Inc. | 2021-10-19 |
| CapSure Epicardial Pacing Lead (P950024/S100) | Medtronic, Inc. | 2021-10-19 |
| HeartWare® Ventricular Assist System (P100047/S190) | Medtronic | 2021-10-18 |
| LifeVest Wearable Defibrillator (P010030/S152) | Zoll Manufacturing Corporation | 2021-10-18 |
| OPTIMIZER Smart System (P180036/S010) | Impulse Dynamics (Usa), Inc. | 2021-10-15 |
| Impella 5.5 with SmartAssist (P140003/S086) | Abiomed, Inc. | 2021-10-15 |
| Micra AV TPS; Micra TPS (P150033/S125) | Medtronic, Inc. | 2021-10-15 |
| HeartWare HVAD System (P100047/S189) | Medtronic | 2021-10-15 |
| Micra AV TPS; Micra TPS (P150033/S124) | Medtronic, Inc. | 2021-10-14 |
| EXCOR Pediatric Ventricular Assist Device (P160035/S020) | Berlin Heart, Inc. | 2021-10-14 |
| 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/S794) | Medtronic Cardiac Rhythm Disease Management | 2021-10-14 |
| Astron Pulsar Stent System (P160025/S012) | Biotronik AG | 2021-10-14 |
| Ampere Generator (P040042/S051) | Irvine Biomedical,Inc.(Ibi) | 2021-10-14 |
| Ampere Generator (P040014/S045) | Irvine Biomedical, Inc. | 2021-10-14 |
| 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/S759) | Medtronic Cardiac Rhythm Disease Management | 2021-10-14 |
| Ampere Generator (P060019/S054) | Irvine Biomedical, Inc. | 2021-10-14 |
| Astron Peripheral Self-Expanding Nitinol Stent System (P140030/S014) | Biotronik AG | 2021-10-14 |
| Ampere Generator (P130026/S076) | St Jude Medical | 2021-10-14 |
| Ampere Generator (P110016/S079) | ABBOTT MEDICAL | 2021-10-14 |
| Ampere Generator (P960016/S088) | St Jude Medical | 2021-10-14 |
| Micra AV TPS; Micra TPS (P150033/S123) | Medtronic, Inc. | 2021-10-13 |
| On-X Ascending Aortic Prosthesis (P000037/S056) | On-X Life Technologies, Inc. | 2021-10-13 |
| Micra AV TPS, Micra TPS (P150033/S122) | Medtronic, Inc. | 2021-10-13 |
| ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM (P110028/S022) | Abbott Vascular, Inc. | 2021-10-12 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT RSR Pericardial Aortic Biopr (P860057/S204) | Edwards Lifesciences, LLC | 2021-10-12 |
| Freezor Cardiac Cryoablation System (P020045/S095) | Medtronic Cryocath, LP | 2021-10-12 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S018) | Celonova Biosciences, Inc. | 2021-10-12 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve. (P140031/S135) | Edwards Lifesciences, LLC | 2021-10-12 |
| ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM (P040012/S062) | Abbott Vascular | 2021-10-12 |
| Edwards Pericardial Aortic Bioprosthesis, INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesis, and t (P150048/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| LifeVest® Wearable Defibrillator (P010030/S153) | Zoll Manufacturing Corporation | 2021-10-12 |
| Edwards INTUITY Elite Valve (P150036/S058) | Edwards Lifesciences, LLC | 2021-10-12 |
| Tack Endovascular System (4F, 1.5-4.5mm) (P190027/S002) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2021-10-08 |
| Innova Self-Expanding Stent System (P140028/S071) | Boston Scientific Corporation | 2021-10-07 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S047) | Boston Scientific Corp | 2021-10-07 |
| Resonate, Momentum, Vigilant, Autogen, Dynagen, Inogen, Origen Cardiac Resynchronization Therapy Defibrillators (P010012/S528) | Boston Scientific Corp | 2021-10-07 |
| Resonate family of CRT-D's (P010012/S540) | Boston Scientific Corp | 2021-10-07 |
| Resonate, Momentum, Vigilant, Perciva, Autogen, Dynagen, Inogen, Origen Implantable Cardioverter Defibrillators (P960040/S459) | Boston Scientific | 2021-10-07 |
| Powerheart G5 Pediatric Electrodes (P160033/S006) | ZOLL Medical Corporation | 2021-10-07 |
| HeartMate II Left Ventricular Assist System (P060040/S080) | ABBOTT MEDICAL | 2021-10-07 |
| Resonate family of CRT-D's (P960040/S466) | Boston Scientific | 2021-10-07 |
| HeartMate 3 Left Ventricular Assist System (P160054/S038) | ABBOTT MEDICAL | 2021-10-07 |
| Subcutaneous Implantable Defibrillator (S-ICD) System (P110042/S163) | Boston Scientific Corporation | 2021-10-06 |
| Ventak Av Aicd Ventak Prizm Dr/Vr, Vitality, Cofient, and Teligen Automatic Implantable Cardioveter Defribillator System (P960004/S098) | Boston Scientific | 2021-10-06 |
| Endoktak Lead System (P910073/S167) | Boston Scientific | 2021-10-06 |
| VenaSeal Closure System (P140018/S028) | Medtronic Vascular, Inc. | 2021-10-06 |
| Optimizer Smart System and Optimizer Smart Mini System (P180036/S008) | Impulse Dynamics (Usa), Inc. | 2021-10-06 |
| Contak CD, EasyTrak, Livian, Cognis, and Acuity Spirial Automatic Implantable Cardiac Resynchronization Therapy Defibril (P010012/S546) | Boston Scientific Corp | 2021-10-06 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S004) | W. L. Gore and Associates, Inc. | 2021-10-06 |
| Rotablatorand ROTAPRO Rotational Atherectomy System, RotaWire Guidewire and wireClip Torquer, ROTAWIRE Drive Guidew (P900056/S194) | Boston Scientific Corp | 2021-10-05 |
| CardioMEMS HF System (P100045/S057) | ABBOTT MEDICAL | 2021-10-05 |
| Ventak and Automatic Implantable Cardioverter Defibrillator (AICD) Systems (P830060/S087) | Boston Scientific | 2021-10-04 |
| Imageready MR Conditional Pacing System and Ingevity Pace/Sense Lead (P150012/S118) | Boston Scientific | 2021-10-04 |
| Thinline Endocardial Pacing Leads (P960004/S097) | Boston Scientific | 2021-10-04 |
| SYNERGY XD Everolimus Eluting Platinum Chromium Coronary Stent System (P150003/S079) | Boston Scientific Corporation | 2021-10-04 |
| Endotak Lead System (P910073/S166) | Boston Scientific | 2021-10-04 |
| Sweet Tip (R) Rx Steroid Eluting Lead (P960006/S054) | Boston Scientific | 2021-10-04 |
| CapSureFix Novus Lead Models 4076 and 5076 (P930039/S232) | Medtronic, Inc. | 2021-10-01 |
| Micra AV TPS, Micra TPS (P150033/S120) | Medtronic, Inc. | 2021-10-01 |
| Zilver Vena Venous Self-Expanding Stent (P200023/S001) | Cook Ireland, Ltd. | 2021-10-01 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S231) | Medtronic, Inc. | 2021-10-01 |
| SUPERA PERIPHERAL STENT SYSTEM (P120020/S027) | Abbott Vascular (Idef Technologies Inc) | 2021-09-30 |
| Mynx Control Vascular Closure Device (VCD) (P040044/S086) | Cordis US Corporation | 2021-09-29 |
| CareLink SmartSync Cobalt, Crome App (P010031/S750) | Medtronic Cardiac Rhythm Disease Management | 2021-09-29 |
| CORDIS EXOSEAL VASCULAR CLOSURE DEVICE (P100013/S021) | Cordis US Corporation | 2021-09-28 |
| Micra AV TPS, Micra TPS (P150033/S119) | Medtronic, Inc. | 2021-09-28 |
| Amplatzer Talisman PFO Occluder (P120021/S020) | ABBOTT MEDICAL | 2021-09-27 |
| ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters (P200004) | Conmed Corporation | 2021-09-26 |
| ACUITY STEERABLE LEAD SYSTEM (P050046/S032) | Guidant Corp. | 2021-09-24 |
| GORE EXCLUDER Iliac Branch Endoprosthesis, GORE EXCLUDER Conformable AAA Endoprothesis (P020004/S182) | W. L. Gore & Associates, Inc. | 2021-09-24 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S758) | Medtronic Cardiac Rhythm Disease Management | 2021-09-24 |
| THINLINE / FINELINE Family of Endocardial Pacing Leads (P960004/S095) | Boston Scientific | 2021-09-24 |
| 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/S692) | Medtronic, Inc. | 2021-09-24 |
| FNLN2 SXP BP, FNLN2 SXP PF BP, FNLN2 SX PF BP, FNLN2 SXP J BP, (P960004/S096) | Boston Scientific | 2021-09-24 |
| S-ICD GEN 2, S-ICD EMBLEM, EMBLEM S-ICD ELECTRODE (P110042/S162) | Boston Scientific Corporation | 2021-09-24 |
| Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD (P980016/S793) | Medtronic Cardiac Rhythm Disease Management | 2021-09-24 |
| SWEET TIP Rx, SWEET PICOTIP Rx, and FLEXTEND (P960006/S053) | Boston Scientific | 2021-09-24 |
| S-ICD, Q-TRAK Subcutaneous Electrode, Q-TECH Programmer and Related Accessories (P110042/S158) | Boston Scientific Corporation | 2021-09-24 |
| GORE® VIABAHN® Endoprosthesis (P040037/S146) | W. L. Gore & Associates, Inc. | 2021-09-24 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System (P130021/S102) | Medtronic, Inc. | 2021-09-24 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S484) | Medtronic, Inc. | 2021-09-24 |
| ORIGEN VR, ORIGEN DR, INOGEN DR, INOGEN VR, DYNAGEN VR, DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL (P960040/S470) | Boston Scientific | 2021-09-24 |
| VALITUDE CRT-P, VISIONIST CRT-P (P030005/S213) | Guidant Corp. | 2021-09-24 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, PROPONENT MRI SR, PROPONENT MRI DR, ACCOLADE MRI SR, ACCOLADE MRI DR, INGEVITY PLUS AF (P150012/S117) | Boston Scientific | 2021-09-24 |
| GORE® VIATORR® TIPS Endoprosthesis and GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S088) | W. L. Gore & Associates, Inc. | 2021-09-24 |
| REL S, REL, REL SEZ, REL EZ DUAL COIL, REL SG, REL G, SEN (P910073/S164) | Boston Scientific | 2021-09-24 |
| EZTRK 2, ACUITY SPIRAL, ORIGEN CRT-D, INOGEN CRT-D, DYNAGEN CRT-D, NAV 2 QUADPOLE, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, VI (P010012/S545) | Boston Scientific Corp | 2021-09-24 |
| HeartStart FRx Defibrillator (861304) (P180028/S010) | Philips Medical Systems | 2021-09-24 |
| ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR (N970003/S268) | Boston Scientific Corp | 2021-09-24 |
| INGEVITY and INGEVITY MRI Leads and Accessories; VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI (P150012/S115) | Boston Scientific | 2021-09-24 |