| Multi-Application Utility Model, (Non-Implantable Accessories) (P910077/S161) | Boston Scientific | 2017-09-20 |
| FINELINE II Sterox Leads, Suture Sleeve Accessory for FINELINE II Leads, (Pacing Leads and Accessories) (P960004/S081) | Boston Scientific | 2017-09-20 |
| NIRxcell CoCr Coronary Stent on RX System (P110004/S025) | Medinol, Ltd. | 2017-09-19 |
| FlexAbility Ablation Catheter & FlexAbility Ablation Catheter, Sensor Enabled (P110016/S049) | ABBOTT MEDICAL | 2017-09-18 |
| Artegraft Collagen Vascular Graft (N16837/S022) | LeMaitre Vascular, Inc. | 2017-09-15 |
| Blazer OI and IntellaNav OI (P150005/S026) | Boston Scientific Corp | 2017-09-15 |
| Resolute Onyx Zotarolimus-Eluting Coronary Stent System (P160043/S006) | Medtronic Vascular | 2017-09-13 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S145) | Boston Scientific Corp | 2017-09-13 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S044) | Boston Scientific Corp | 2017-09-13 |
| Express LD LLiac Premounted Stent System (P090003/S043) | Boston Scientific Corporation | 2017-09-13 |
| Synerg Everolimus Eluting Conronary Stent System (P150003/S033) | Boston Scientific Corporation | 2017-09-13 |
| HeartWare Left Ventricular Assist System (P100047/S107) | Medtronic | 2017-09-13 |
| Express SD Renal Premounted Stent System (P060006/S086) | Boston Scientific Corp | 2017-09-13 |
| BioGlue Surgical Adhesive (P010003/S028) | Cryolife, Inc. | 2017-09-12 |
| Advantio, Ingenio, Vitalio, Formio, Essentio, Accolade, Proponent, Altrua 2 Pacemakers (N970003/S204) | Boston Scientific Corp | 2017-09-11 |
| Torque Wrench (N970003/S208) | Boston Scientific Corp | 2017-09-11 |
| Quadra Assura MP CRT-D, Quadra Assura CRT-D, Unify Assura CRT-D, Unify Quadra CRT-D, Promote Quadra CRT-D, Promote Q CRT (P030054/S336) | ABBOTT MEDICAL | 2017-09-11 |
| PK-222 and PK-Electrode Clip (accessory to Renamic) (P950037/S180) | Biotronik, Inc. | 2017-09-11 |
| Endurity MRI ,Assurity MRI Pacemaker (P140033/S013) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P010012/S458) | Boston Scientific Corp | 2017-09-11 |
| Ellipse. Fortify Assura, Fortify, Current Accel, Current+, Current ICDs (P910023/S392) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P960040/S398) | Boston Scientific | 2017-09-11 |
| Cognis, Energen, Punctua, Incepta, Origen, Inogen, Dynagen, Autogen CRT-Ds (P010012/S448) | Boston Scientific Corp | 2017-09-11 |
| OUS Vitatron Application Software (P890003/S377) | Medtronic, Inc. | 2017-09-11 |
| Invive, Intua, Visionist, Valitude (P030005/S152) | Guidant Corp. | 2017-09-11 |
| Torque Wrench (P110042/S088) | Boston Scientific Corporation | 2017-09-11 |
| Quadra Allura MP RF CRT-P. Quadra Allure MP CRT-P, Allura Quadra CRT-P, Anthem RF CRT-P, Frontier II CRT-P Pacemakers (P030035/S159) | ABBOTT MEDICAL | 2017-09-11 |
| INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, ACCOLADE MRI, PROPONENT MRI (P150012/S039) | Boston Scientific | 2017-09-11 |
| Torque Wrench (P030005/S156) | Guidant Corp. | 2017-09-11 |
| HeartWare Ventricular Assist System (P100047/S108) | Medtronic | 2017-09-11 |
| Microny Pacemakers (P970013/S072) | ABBOTT MEDICAL | 2017-09-11 |
| Current+, Fortify, Fortify Assura, Ellipse (P910023/S389) | ABBOTT MEDICAL | 2017-09-11 |
| Allure. Allure Quadra (P030035/S158) | ABBOTT MEDICAL | 2017-09-11 |
| Endurity Core, Endurity, Assurity+, Assurity, Sistain, Accent, Zephyr, Victory, Verify ADx XL, Identity Adx, Identity Pa (P880086/S287) | ABBOTT MEDICAL | 2017-09-11 |
| LATITUDE Programming System (P910077/S159) | Boston Scientific | 2017-09-11 |
| Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, and Quadra Assura MP (P030054/S333) | ABBOTT MEDICAL | 2017-09-11 |
| Assurity, Assurity+, and Endurity (P880086/S286) | ABBOTT MEDICAL | 2017-09-11 |
| Torque Wrench (P150012/S033) | Boston Scientific | 2017-09-11 |
| S-ICD (Subcutaneous-ICD) Telemetry Wand (P110042/S083) | Boston Scientific Corporation | 2017-09-11 |
| Teligen, Energen, Puntua, Incepta, Origen, Inogen, Dynagen, Autogen (P960040/S391) | Boston Scientific | 2017-09-11 |
| Gore Viabahn Endoprosthesis and Endoprosthesis with Heparin Bioactive Surface (P130006/S040) | W. L. Gore & Associates, Inc. | 2017-09-08 |
| Viabhan Endoprosthesis and endoprosthesis with Heparin Bioactive Surface (P040037/S101) | W. L. Gore & Associates, Inc. | 2017-09-08 |
| TMR Holmium Laser System (P970029/S036) | Cryolife, Inc. | 2017-09-08 |
| Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis/Theon Pericardial Aortic Bioprosthesis with ThermaFix tiss (P860057/S168) | Edwards Lifesciences, LLC | 2017-09-07 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S116) | MicroPort CRM USA, Inc. | 2017-09-07 |
| Flextome Cutting Balloon Microsurgical Dilation Device (P950020/S083) | Boston Scientific Corp | 2017-09-07 |
| Edwards Pericardial Aortic Bioprosthesis/Inspiris Resilia Aortic Valve (P150048/S004) | Edwards Lifesciences, LLC | 2017-09-07 |
| Edwards Intuity Elite Valve System (P150036/S018) | Edwards Lifesciences, LLC | 2017-09-07 |
| Open-Irrigated Ablation Catheters: Blazer OI, IntellaTip MiFi OI, and IntellaNav OI (P150005/S025) | Boston Scientific Corp | 2017-09-06 |
| Cardiomems HF Pressure Measurement System (P100045/S024) | ABBOTT MEDICAL | 2017-09-06 |
| Ovation iX Abdominal Stent Graft System (P120006/S029) | Endologix, LLC | 2017-09-05 |
| HV splitter/adaptor kit 5019 (P920015/S202) | Medtronic, Inc. | 2017-09-05 |
| Resolute Onyx Coronary Stent Systems (P160043/S005) | Medtronic Vascular | 2017-09-01 |
| ELCA Coronary Laser Atherectomy Catheters (P910001/S098) | Spectranetics Corp. | 2017-09-01 |
| EVERA MRI DF-1/ DF-1 ICD/MRI ICD/ EVERA XT DR ICD/ VR ICD; PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR ICD; VISIA AF (P980016/S616) | Medtronic, Inc. | 2017-09-01 |
| AMPLIA MRI CRT-D /QUAD CRT-D; CLARIA MRI CRT-D/QUAD CRT-D; COMPIA MRI CRT-D /QUAD CRT-D; CONCERTO ICD & II CRT-D; CONSUL (P010031/S575) | Medtronic, Inc. | 2017-09-01 |
| Resolute Integrity Zotarolimus Eluting Coronary Stent Systems (P110013/S081) | Medtronic Vascular | 2017-09-01 |
| SYNERGYST II PULSE GENERATOR (P890003/S372) | Medtronic, Inc. | 2017-09-01 |
| CONSULTA CRT-P & VIVA CRT-P (P010015/S318) | Medtronic, Inc. | 2017-09-01 |
| EDWARDS INTUITY Elite Valve System (P150036/S017) | Edwards Lifesciences, LLC | 2017-08-31 |
| Arctic Front Advance Catheters (P100010/S066) | Medtronic Cryocath, LP | 2017-08-31 |
| Rotablator Rotational Angioplasty System Guidewire (P900056/S164) | Boston Scientific Corp | 2017-08-31 |
| Rebel Platinum Chromium Coronary Stent System (Monorail and Over-the-Wire) (P130030/S043) | Boston Scientific Corp | 2017-08-31 |
| PSW 1703.U (P000009/S074) | Biotronik, Inc. | 2017-08-31 |
| Express SD Monorail Premounted Stent System (P060006/S085) | Boston Scientific Corp | 2017-08-31 |
| Wolverine Coronary Cutting Balloon (Monorail and Over-The-Wire) (P950020/S082) | Boston Scientific Corp | 2017-08-31 |
| Chilli II Cooled RF Ablation system (P980003/S078) | Boston Scientific Corp | 2017-08-31 |
| Blazer II Cardiac Ablation System (P920047/S101) | Boston Scientific Corp | 2017-08-31 |
| PSW 1703.U (P070008/S085) | Biotronik, Inc. | 2017-08-31 |
| Blazer II XP Cardiac RF Ablation System (P020025/S105) | Boston Scientific | 2017-08-31 |
| En Veo R Delivery Catheter System (P130021/S040) | Medtronic, Inc. | 2017-08-31 |
| PSW 1703.U (P950037/S179) | Biotronik, Inc. | 2017-08-31 |
| PSW 1703.U (P050023/S112) | Biotronik, Inc. | 2017-08-31 |
| Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S144) | Boston Scientific Corp | 2017-08-31 |
| TMR Holmium Laser System (P970029/S034) | Cryolife, Inc. | 2017-08-31 |
| Blazer Open Irrigated Cardiac Ablation System (P150005/S024) | Boston Scientific Corp | 2017-08-31 |
| Accolade MRI Pacemakers, Essentio MRI, Proponent MRI, Accolade MRI (P150012/S035) | Boston Scientific | 2017-08-30 |
| Accolade Cardiac Resynchronization Therapy Pacemaker Devices- Valitude, Valitude X4, Visionist and Visionist X4 (P030005/S158) | Guidant Corp. | 2017-08-30 |
| Accolade Non-MRI Pacemakers , Altrua, Essentio, Proponent, Accolade (N970003/S210) | Boston Scientific Corp | 2017-08-30 |
| PreveLeak Surgical Sealant / PreveLeak Surgical 10pk applicator tips (P100030/S011) | Baxter Healthcare Corporation | 2017-08-30 |
| NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re (P960040/S399) | Boston Scientific | 2017-08-30 |
| ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF (P960040/S401) | Boston Scientific | 2017-08-30 |
| NG3 Cardiac Resynchronization Therapy- Defibrillator Devices , Autogen Dynagen, Inogen, Origen , Momentum, Vigilant, Res (P010012/S459) | Boston Scientific Corp | 2017-08-30 |
| CRT-P VALITUDE, VISIONIST (P030005/S159) | Guidant Corp. | 2017-08-30 |
| Pacemakers: ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI (P150012/S036) | Boston Scientific | 2017-08-30 |
| CRT-Ds: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, VIGILANT, MOMENTUM, RESONATE, PUNCTUA, ENERGEN, INCEPTA (P010012/S460) | Boston Scientific Corp | 2017-08-30 |
| Pacemakers: ESSENTIO, PROPONENT, ACCOLADE, ALTRUA 2 (N970003/S211) | Boston Scientific Corp | 2017-08-30 |
| ICD; S-ICD, EMBLEM S-ICD MRI (P110042/S091) | Boston Scientific Corporation | 2017-08-30 |
| Innova Self-Expanding Stent System (P140028/S028) | Boston Scientific Corporation | 2017-08-29 |
| Percepta, Serena, Solara Bipolar/Quadripolar CRT-P (P010015/S338) | Medtronic, Inc. | 2017-08-29 |
| ASTRA XT DR/SR/MRI/IPG (P980035/S513) | Medtronic, Inc. | 2017-08-29 |
| LIFEVEST WEARABLE DEFIBRILLATOR (P010030/S090) | Zoll Manufacturing Corporation | 2017-08-29 |
| LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 (P170003) | Lutonix | 2017-08-25 |
| Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P (P010015/S341) | Medtronic, Inc. | 2017-08-25 |
| ASTRA S DR MRI IPG X3DR01; ASTRA S SR MRI IPG X3SR01; ASTRA XT DR MRI IPG X1DR01; ASTRA XT SR MRI IPG X1SR01 (P980035/S517) | Medtronic, Inc. | 2017-08-25 |
| ELCA Laser Catheters (P910001/S096) | Spectranetics Corp. | 2017-08-25 |
| Carpentier-Edwards PERIMOUNT Theon/RSR/Magna/Magna Ease Pericardial Aortic Bioprothesis / ThermaFix Tissue Process (P860057/S167) | Edwards Lifesciences, LLC | 2017-08-24 |
| EDWARDS INTUITY ELITE Valve System (P150036/S016) | Edwards Lifesciences, LLC | 2017-08-24 |
| HeartMate 3 Left Ventricular Assist System (P160054) | ABBOTT MEDICAL | 2017-08-23 |
| Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (P910023/S386) | ABBOTT MEDICAL | 2017-08-23 |