| PSW 1904.U (P050023/S145) | Biotronik, Inc. | 2020-05-29 |
| IntellaNav MiFi Open-Irrigated Ablation Catheter (P150005/S054) | Boston Scientific Corp | 2020-05-29 |
| Bard E-Luminexx Vascular Stent (P080007/S023) | Bard Peripheral Vascular, Inc. | 2020-05-29 |
| PSW 1904.U (P070008/S115) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P950037/S211) | Biotronik, Inc. | 2020-05-29 |
| PSW 1904.U (P000009/S084) | Biotronik, Inc. | 2020-05-29 |
| Cordis PRECISE Nitinol Stent System (P030047/S040) | Cordis US Corporation | 2020-05-29 |
| PSW 1904.U (P980023/S100) | Biotronik, Inc. | 2020-05-29 |
| IntellaNav OI, and IntellaNav MiFi OI (P150005/S055) | Boston Scientific Corp | 2020-05-28 |
| SYNERGY XD Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail) (P150003/S055) | Boston Scientific Corporation | 2020-05-28 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S032) | Medtronic Vascular | 2020-05-28 |
| Evolut R, Evolut PRO and Evolut PRO+ Systems (P130021/S072) | Medtronic, Inc. | 2020-05-28 |
| EMBLEM Subcutaneous Implantable Cardioverter-Defibrillator (S-ICD) (P110042/S138) | Boston Scientific Corporation | 2020-05-28 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S060) | St Jude Medical | 2020-05-28 |
| Cobalt XT DR MRI SureScan, Cobalt DR MRI SureScan, Crome DR MRI SureScan, Cobalt XT VR MRI SureScan, Cobalt VR MRI SureS (P980016/S740) | Medtronic Cardiac Rhythm Disease Management | 2020-05-27 |
| Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT- (P010031/S701) | Medtronic Cardiac Rhythm Disease Management | 2020-05-27 |
| SJM Masters Valved Graft with Hemashield graft technology (P810002/S112) | ABBOTT MEDICAL | 2020-05-26 |
| 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/S626) | Medtronic, Inc. | 2020-05-26 |
| MANTA Vascular Closure Device (P180025/S007) | Teleflex Medical, LLC | 2020-05-26 |
| VICI VENOUS STENT System (P180013/S005) | Boston Scientific Corporation | 2020-05-26 |
| AMPLATZER PFO Occluder (P120021/S017) | ABBOTT MEDICAL | 2020-05-23 |
| AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo) (P020024/S063) | ABBOTT MEDICAL | 2020-05-23 |
| AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder (P000039/S072) | ABBOTT MEDICAL | 2020-05-23 |
| AMPLATZER Muscular VSD Occluder (P040040/S042) | ABBOTT MEDICAL | 2020-05-23 |
| GORE VIABAHN Endoprosthesis, GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P040037/S138) | W. L. Gore & Associates, Inc. | 2020-05-22 |
| Drug-Eluting Permanent Defibrillator Electrodes (P980023/S099) | Biotronik, Inc. | 2020-05-22 |
| Tendril MRI (P140033/S057) | ABBOTT MEDICAL | 2020-05-22 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S077) | W. L. Gore & Associates, Inc. | 2020-05-22 |
| CentriMag Circulatory Support System (P170038/S002) | Abbott | 2020-05-22 |
| Single/Dual Chamber ICD Systems, Bipolar CRT-D Systems and Acticor and Rivacor 1.5 T and 3.0 T ICD and CRT-D Systems (P050023/S144) | Biotronik, Inc. | 2020-05-22 |
| Quadripolar CRT-D Systems (P070008/S114) | Biotronik, Inc. | 2020-05-22 |
| Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust (P880086/S313) | ABBOTT MEDICAL | 2020-05-21 |
| Allure, Allure Quadra, and Quadra Allure MP (P030035/S181) | ABBOTT MEDICAL | 2020-05-21 |
| Micra AV TPS, Micra TPS (P150033/S072) | Medtronic, Inc. | 2020-05-21 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S031) | Boston Scientific Corp | 2020-05-21 |
| Edwards Commander Delivery System (P140031/S115) | Edwards Lifesciences, LLC | 2020-05-21 |
| Fortify, Fortify Assura, and Ellipse (P910023/S427) | ABBOTT MEDICAL | 2020-05-21 |
| Assurity MRI and Endurity MRI (P140033/S058) | ABBOTT MEDICAL | 2020-05-21 |
| Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads (P030054/S378) | ABBOTT MEDICAL | 2020-05-21 |
| Arctic Front Advance Cardiac Cryoablation Catheter (P100010/S104) | Medtronic Cryocath, LP | 2020-05-20 |
| LIFEPAK CR2 Automated External Defibrillator (AED) (P170018/S006) | Physio-Control, Inc. | 2020-05-20 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S092) | Boston Scientific Corp | 2020-05-19 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S059) | Boston Scientific Corporation | 2020-05-19 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S126) | Boston Scientific | 2020-05-19 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S184) | Boston Scientific Corp | 2020-05-19 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S053) | Boston Scientific Corp | 2020-05-19 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S122) | Boston Scientific Corp | 2020-05-19 |
| Innova Self-Expanding Stent System (P140028/S056) | Boston Scientific Corporation | 2020-05-19 |
| Eluvia Drug-Eluting Vascular Stent System (P180011/S028) | Boston Scientific Corp | 2020-05-19 |
| Express SD Monorail Premounted Stent System (P060006/S100) | Boston Scientific Corp | 2020-05-19 |
| Epic Vascular Self-Expanding Stent System (P110035/S057) | Boston Scientific Corp | 2020-05-19 |
| WOLVERINE Coronary Cutting Balloon (P950020/S106) | Boston Scientific Corp | 2020-05-19 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S079) | Boston Scientific Corp | 2020-05-19 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S067) | Boston Scientific Corp | 2020-05-19 |
| PROMUS Element PLUS/PREMIER/ELITE Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S176) | Boston Scientific Corp | 2020-05-19 |
| SJM Masters HP Valved Graft (P810002/S108) | ABBOTT MEDICAL | 2020-05-18 |
| CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol (P010015/S430) | Medtronic, Inc. | 2020-05-17 |
| Durata and Optisure High Voltage Lead (P950022/S112) | ABBOTT MEDICAL | 2020-05-17 |
| CareLink SmartSync Azure Astra Application, Azure S DR MRI IPG Azure S sR MRI IRG and Azure XT DR/SR MRI IPG (P980035/S619) | Medtronic, Inc. | 2020-05-17 |
| CareLink SmartSync Platform and Common Application (P890003/S428) | Medtronic, Inc. | 2020-05-17 |
| MyCareLink Patient Monitor (P890003/S427) | Medtronic, Inc. | 2020-05-15 |
| Optisure High Voltage Leads (P950022/S131) | ABBOTT MEDICAL | 2020-05-15 |
| Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, (P980035/S616) | Medtronic, Inc. | 2020-05-15 |
| 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/S730) | Medtronic Cardiac Rhythm Disease Management | 2020-05-15 |
| Micra TPS, Micra AV (P150033/S067) | Medtronic, Inc. | 2020-05-15 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S035) | Cook Ireland, Ltd. | 2020-05-15 |
| Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola (P010015/S428) | Medtronic, Inc. | 2020-05-15 |
| 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/S691) | Medtronic Cardiac Rhythm Disease Management | 2020-05-15 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P170003/S017) | Lutonix | 2020-05-14 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S034) | Lutonix | 2020-05-14 |
| LifeVest Wearable Defibrillator (P010030/S137) | Zoll Manufacturing Corporation | 2020-05-14 |
| LOTUS Edge Valve System (P180029/S023) | Boston Scientific Corporation | 2020-05-13 |
| Assurity, Endurity Core Family of Pacemakers (P880086/S306) | ABBOTT MEDICAL | 2020-05-13 |
| LIFEPAK CR Plus defibrillator and LIFEPAK EXPRESS defibrillator (P160012/S004) | Physio-Control, Inc. | 2020-05-13 |
| Assurity MRI, Endurity MRI family of Pacemakers (P140033/S048) | ABBOTT MEDICAL | 2020-05-13 |
| Mechanical Heart Valve (P810002/S111) | ABBOTT MEDICAL | 2020-05-12 |
| SelectSecure Lead (P030036/S120) | Medtronic Cardiac Rhythm Disease Management | 2020-05-11 |
| Defibrillator, Automatic Implantable Cardioverter with Cardiac Resynchronization (CRT-D), Implantable Cardioverter Defib (P050023/S139) | Biotronik, Inc. | 2020-05-11 |
| Defibrillator, Implantable Dual-Chamber (P000009/S082) | Biotronik, Inc. | 2020-05-11 |
| Pulse Generator, Permanent, Implantable (P950037/S207) | Biotronik, Inc. | 2020-05-11 |
| HeartStart FRx Defibrillator (P180028) | Philips Medical Systems | 2020-05-11 |
| Philips HeartStart FR3 Defibrillator (P160028) | Philips Medical Systems, Inc. | 2020-05-11 |
| Implantable Cardioverter Defibrillator (Non-CRT) (P980023/S096) | Biotronik, Inc. | 2020-05-11 |
| Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P) (P070008/S110) | Biotronik, Inc. | 2020-05-11 |
| Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD (P980016/S731) | Medtronic Cardiac Rhythm Disease Management | 2020-05-08 |
| Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad (P010031/S692) | Medtronic Cardiac Rhythm Disease Management | 2020-05-08 |
| Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P (P010015/S429) | Medtronic, Inc. | 2020-05-08 |
| HeartLight Endoscopic Ablation System (P150026/S008) | Cardiofocus, Inc. | 2020-05-08 |
| 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/S618) | Medtronic, Inc. | 2020-05-08 |
| HeartWare HVAD System (P100047/S142) | Medtronic | 2020-05-07 |
| HeartWare Ventricular Assist System (P100047/S161) | Medtronic | 2020-05-06 |
| SLS/GlideLight (P960042/S069) | Spectranetics (Philips) | 2020-05-06 |
| EXCOR blood pumps with Injection Molded Housing (P160035/S014) | Berlin Heart, Inc. | 2020-05-06 |
| Hancock II Bioprothesis (P980043/S073) | Medtronic, Inc. | 2020-05-06 |
| Artegraft Collagen Vascular Graft (N16837/S026) | LeMaitre Vascular, Inc. | 2020-05-06 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S061) | Boston Scientific Corporation | 2020-05-06 |
| Promus Premier, Promus Elite Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S178) | Boston Scientific Corp | 2020-05-06 |
| Innova Vascular Self-Expanding Stent with Delivery System (P140028/S055) | Boston Scientific Corporation | 2020-05-05 |
| AngioJet Rheolythic Thrombectomy Catheter (P980037/S078) | Boston Scientific Corp | 2020-05-05 |
| CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV) (P130021/S075) | Medtronic, Inc. | 2020-05-05 |