| Venous Wallstent and Wallstent Venous Endoprosthesis with Unistep Plus Delivery System (P980033/S060) | Boston Scientific Corporation | 2022-10-14 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System and Promus Elite Everolimus-Eluting Platinum C (P110010/S195) | Boston Scientific Corp | 2022-10-14 |
| Artegraft Collagen Vascular Graft (N16837/S028) | LeMaitre Vascular, Inc. | 2022-10-14 |
| 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/S837) | Medtronic Cardiac Rhythm Disease Management | 2022-10-14 |
| GORE CARDIOFORM Septal Occluder, GORE CARDIOFORM ASD Occluder (P050006/S101) | W. L. Gore & Associates, Inc. | 2022-10-14 |
| REALIANCE 4-SITE Family of Defibrillation Leads (P910073/S169) | Boston Scientific | 2022-10-14 |
| ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, VIGILANT CRT-D, VIGILANT X4 CR (P010012/S563) | Boston Scientific Corp | 2022-10-14 |
| Endurant Stent Graft System, Endurant II Stent Graft System, Endurant IIs Stent Graft System (P100021/S107) | Medtronic Vascular | 2022-10-13 |
| EPi-Sense® Guided Coagulation System and EPi-Sense ST Coagulation System (P200002/S003) | AtriCure, Inc. | 2022-10-13 |
| Micra Transcatheter Pacing System, Micra AV TPS (P150033/S154) | Medtronic, Inc. | 2022-10-12 |
| Ranger Paclitaxel-Coated PTA Balloon Catheter (P190019/S014) | Boston Scientific Corporation | 2022-10-12 |
| DiamondTemp Ablation System with the EnSite X Mapping System (P200028/S012) | Medtronic, Inc. | 2022-10-12 |
| IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P190008/S020) | Medtronic Vascular, Inc. | 2022-10-11 |
| Impella RP and Impella RP with SmartAssist (P170011/S046) | Abiomed, Inc. | 2022-10-11 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and 3 IN.PACT 018 Paclita (P140010/S068) | Medtronic, Inc. | 2022-10-11 |
| Perceval PLUS Sutureless Heart Valve (P150011/S024) | Corcym S.r.l. | 2022-10-07 |
| Aveir (P150035/S002) | ABBOTT MEDICAL | 2022-10-06 |
| CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application, CareLink Sm (P890003/S456) | Medtronic, Inc. | 2022-10-06 |
| Impella RP, Impella RP with SmartAssist (P170011/S044) | Abiomed, Inc. | 2022-10-06 |
| CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application (P010031/S796) | Medtronic Cardiac Rhythm Disease Management | 2022-10-06 |
| CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application (P980016/S830) | Medtronic Cardiac Rhythm Disease Management | 2022-10-06 |
| Conformable GORE® TAG® Conformable Thoracic Stent Graft w/ ACTIVE CONTROL System (CMDS) (P040043/S131) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| GORE® TAG® Thoracic Branch Endoprosthesis (TBE) (P210032/S004) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| GORE® EXCLUDER® AAA Endoprosthesis (AAA) (P020004/S192) | W. L. Gore & Associates, Inc. | 2022-10-05 |
| GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) (P200030/S010) | W. L. Gore and Associates, Inc. | 2022-10-05 |
| Myopore® Sutureless Myocardial Pacing Lead (P130012/S009) | Great Batch Medical | 2022-10-05 |
| Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol (P130021/S120) | Medtronic, Inc. | 2022-10-04 |
| Impella 5.5 with SmartAssist (P140003/S094) | Abiomed, Inc. | 2022-10-04 |
| Medtronic SelectSecure MRI SureScan Lead (P030036/S139) | Medtronic Cardiac Rhythm Disease Management | 2022-10-03 |
| Microny family of Pacemakers (P970013/S091) | ABBOTT MEDICAL | 2022-09-30 |
| Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter (P030031/S128) | Biosense Webster, Inc. | 2022-09-30 |
| Celsius FLTRR, EZ Steer Nav DS Catheter (P010068/S070) | Biosense Webster, Inc. | 2022-09-30 |
| Assurity, Assurity+, Endurity, Accent family of Pacemakers (P880086/S325) | ABBOTT MEDICAL | 2022-09-30 |
| HeartWare HVAD System (P100047/S196) | Medtronic | 2022-09-30 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and (P910023/S447) | ABBOTT MEDICAL | 2022-09-30 |
| Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (P030054/S401) | ABBOTT MEDICAL | 2022-09-30 |
| NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter, (P990025/S070) | Biosense Webster, Inc. | 2022-09-30 |
| Biosense Webster Cables (P990071/S056) | Biosense Webster, Inc. | 2022-09-30 |
| Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St (P950005/S085) | Biosense Webster, Inc. | 2022-09-30 |
| Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (P030035/S191) | ABBOTT MEDICAL | 2022-09-30 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S075) | ABBOTT MEDICAL | 2022-09-30 |
| ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV (P040036/S090) | Biosense Webster, Inc. | 2022-09-30 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S126) | Boston Scientific Corp | 2022-09-30 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S060) | Medtronic Vascular | 2022-09-29 |
| Thoraflex Hybrid (P210006/S003) | Vascutek, Ltd. | 2022-09-29 |
| Resolute Integrity (P110013/S117) | Medtronic Vascular | 2022-09-29 |
| Tack Endovascular System (6F) (P180034/S006) | Philips Image Guided Therapy Corporation | 2022-09-29 |
| Tack Endovascular System (4F) (P190027/S003) | Philips Image Guided Therapy Corporation (Formerly Intact) | 2022-09-29 |
| VALITUDE CRT-P, VALITUDE X4 CRT-P (P030005/S221) | Guidant Corp. | 2022-09-27 |
| ESSENTIO SR, ESSENTIO DR, ESSENTIO EL DR, PROPONENT SR, PROPONENT DR, PROPONENT EL DR, ACCOLADE SR, ACCOLADE DR, ACCO (N970003/S276) | Boston Scientific Corp | 2022-09-27 |
| EMBLEM S-ICD, EMBLEM MRI S ICD (P110042/S172) | Boston Scientific Corporation | 2022-09-27 |
| EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System (P130021/S122) | Medtronic, Inc. | 2022-09-27 |
| ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD (P150012/S130) | Boston Scientific | 2022-09-27 |
| LIFEPAK® CR2 Defibrillator (P170018/S014) | Physio-Control, Inc. | 2022-09-27 |
| ORIGEN MINI ICD VR, ORIGEN MINI ICD DR, INOGEN MINI ICD VR, INOGEN MINI ICD DR, DYNAGEN MINI ICD VR, DYNAGEN MINI ICD (P960040/S481) | Boston Scientific | 2022-09-27 |
| 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/S557) | Boston Scientific Corp | 2022-09-27 |
| SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) System (P140031/S145) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve, Edwards Pericardial Mitral Bioprosthesi (P150048/S068) | Edwards Lifesciences, LLC | 2022-09-23 |
| EDWARDS INTUITY Elite Valve System (P150036/S064) | Edwards Lifesciences, LLC | 2022-09-23 |
| Carpentier-Edwards® PERIMOUNT ®Pericardial Aortic Bioprosthesis, Carpentier-Edwards PERIMOUNT Theon® Pericardial Aortic (P860057/S209) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve (P200015/S027) | Edwards Lifesciences, LLC | 2022-09-23 |
| Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards SAPIEN 3 Ultra Transcatheter Heart Valve, Edwards SAPIEN 3 Ultr (P140031/S144) | Edwards Lifesciences, LLC | 2022-09-23 |
| GORE® CARDIOFORM Septal Occluder (GSO) (P050006/S102) | W. L. Gore & Associates, Inc. | 2022-09-23 |
| Arctic Front Advance Pro Cardiac CryoAblation Catheters (P100010/S130) | Medtronic Cryocath, LP | 2022-09-23 |
| SynCardia temporary Total Artificial Heart (TAH-t) System (P030011/S082) | Syncardia Systems, LLC | 2022-09-22 |
| 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/S729) | Medtronic, Inc. | 2022-09-21 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S506) | Medtronic, Inc. | 2022-09-21 |
| BLAZER II XP Temperature Ablation Catheter, BLAZER PRIME XP Temperature Ablation Catheter, INTELLATIP MIFI XP Tempe (P020025/S136) | Boston Scientific | 2022-09-21 |
| AngelMed Guardian System (P150009/S008) | Avertix Medical, Inc. | 2022-09-21 |
| INTELLANAV ST Ablation Catheter, BLAZER II Temperature Ablation Catheter, BLAZER II HTD Temperature Ablation Cathete (P920047/S128) | Boston Scientific Corp | 2022-09-21 |
| BLAZER OPEN-IRRIGATED Ablation Catheter, INTELANAV OPEN-IRRIGATED Ablation Catheter, INTELLANAV MIFI OPEN-IRRIGATED A (P150005/S071) | Boston Scientific Corp | 2022-09-21 |
| 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/S802) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, (P980016/S836) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (P010031/S801) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD (P980016/S835) | Medtronic Cardiac Rhythm Disease Management | 2022-09-19 |
| Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG (P980035/S728) | Medtronic, Inc. | 2022-09-16 |
| Micra AV TPS, Micra TPS (P150033/S152) | Medtronic, Inc. | 2022-09-16 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System, Onyx Frontier Zotarolimus-Eluting Coronary Stent System (P160043/S058) | Medtronic Vascular | 2022-09-15 |
| 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/S730) | Medtronic, Inc. | 2022-09-15 |
| Micra AV TPS, Micra TPS (P150033/S151) | Medtronic, Inc. | 2022-09-15 |
| Sprint Quattro Lead (P920015/S271) | Medtronic, Inc. | 2022-09-15 |
| CardioMEMS HF System (P100045/S063) | ABBOTT MEDICAL | 2022-09-15 |
| CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead (P930039/S245) | Medtronic, Inc. | 2022-09-15 |
| Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P) (P070008/S139) | Biotronik, Inc. | 2022-09-15 |
| WOLVERINE Coronary Cutting Balloon® (P950020/S125) | Boston Scientific Corp | 2022-09-15 |
| CapSure Sense Lead, Vitatron Crystalline Lead (P830061/S208) | Medtronic Cardiac Rhythm Disease Management | 2022-09-15 |
| CapSureFix MRI Lead (P090013/S324) | Medtronic, Inc. | 2022-09-15 |
| Pulse Generator, Permanent, Implantable (P950037/S238) | Biotronik, Inc. | 2022-09-15 |
| PASCAL Precision Transcatheter Valve Repair System (P220003) | Edwards Lifesciences, LLC | 2022-09-14 |
| XIENCE Alpine Everolimus Eluting Coronary Stent System, XIENCE Sierra Everolimus Eluting Coronary Stent System, XIENCE S (P110019/S122) | Abbott Vascular | 2022-09-14 |
| VenaSeal Closure System (P140018/S034) | Medtronic Vascular, Inc. | 2022-09-13 |
| GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) (P020004/S191) | W. L. Gore & Associates, Inc. | 2022-09-13 |
| Carpentier-Edwards® PERIMOUNT Family of Pericardial Bioprostheses (P860057/S208) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KON (P150048/S067) | Edwards Lifesciences, LLC | 2022-09-12 |
| Edwards INTUITY Elite Valve System (P150036/S063) | Edwards Lifesciences, LLC | 2022-09-12 |
| CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR (P030031/S127) | Biosense Webster, Inc. | 2022-09-09 |
| Medtronic Evolut FX Delivery Catheter and Loading Systems (P130021/S121) | Medtronic, Inc. | 2022-09-09 |
| CELSIUS (P950005/S084) | Biosense Webster, Inc. | 2022-09-09 |
| MitraClip Clip Delivery System (P100009/S047) | ABBOTT MEDICAL | 2022-09-09 |
| Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR (P910023/S448) | ABBOTT MEDICAL | 2022-09-09 |