| DIPLOS MODEL 05 A & B (P820076/S026) | Biotronik, Inc. | 2018-02-21 |
| NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per (P960040/S420) | Boston Scientific | 2018-02-21 |
| Corox OTW BP/OTW-S BP; Corox OTW-L BP/ProMRI OTW-L BP; Corox ProMRI OTW BP/ProMRI OTW-SBP; Sentus ProMRI OTW QP S/ProMRI (P070008/S089) | Biotronik, Inc. | 2018-02-21 |
| XIENCE V Everolimus Eluting Coronary Stent System (P070015/S140) | Abbott Vascular, Inc. | 2018-02-21 |
| Protego SD/TD/S/T; Protego DF-1 SD/DF-1S; Protego ProMRI SDX/DF-1 ProMRI SDX; Protego DF-1 ProMRI SD/DF-1 ProMRI S; Plex (P980023/S084) | Biotronik, Inc. | 2018-02-21 |
| WATCHMAN Left Atrial Appendage Closure Technology (P130013/S017) | Boston Scientific Corp | 2018-02-21 |
| Micra TPS MC1VR01 (P150033/S031) | Medtronic, Inc. | 2018-02-21 |
| Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P130006/S048) | W. L. Gore & Associates, Inc. | 2018-02-20 |
| Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin Bioactive Surface (P040037/S109) | W. L. Gore & Associates, Inc. | 2018-02-20 |
| Impella RP System (P170011/S002) | Abiomed, Inc. | 2018-02-16 |
| PROMUS Element Plus Everolimus-Eiuting Stent System/ PROMUS PREMIER Everolimus-Eiuting Platinum Chromium Coronary Stent (P110010/S152) | Boston Scientific Corp | 2018-02-16 |
| Rotablator Rotational Atherectomy System (P900056/S169) | Boston Scientific Corp | 2018-02-16 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S048) | Boston Scientific Corp | 2018-02-16 |
| Express SD Monorail Premounted Stent System (P060006/S090) | Boston Scientific Corp | 2018-02-16 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S097) | Abbott Vascular, Inc. | 2018-02-16 |
| Blazer Open Irrigated Temperature Ablation Catheter (P150005/S034) | Boston Scientific Corp | 2018-02-16 |
| Impella RP System (P170011/S003) | Abiomed, Inc. | 2018-02-16 |
| Blazer II Cardiac Ablation Catheter and Cable (P920047/S107) | Boston Scientific Corp | 2018-02-16 |
| Blazer II XP Cardiac Ablation Catheter and Cable (P020025/S110) | Boston Scientific | 2018-02-16 |
| Chilli II Cooled Ablation Catheter and Cable (P980003/S084) | Boston Scientific Corp | 2018-02-16 |
| Stratos LV CRT-P / Stratos LV-T CRT-P / Corox OTW BP Lead / Corox OTW-S BP Lead (P070008/S088) | Biotronik, Inc. | 2018-02-15 |
| Tupoa LV/ATX & Kronos LV-T / CRT-D & Corox OWT Steroid LV Pacing Lead (P050023/S114) | Biotronik, Inc. | 2018-02-15 |
| Misago RX Self-expanding Peripheral Stent (P140002/S009) | Terumo Medical Corporation | 2018-02-15 |
| Phylax Implantable Cardioverter Defibrillator System (P980023/S082) | Biotronik, Inc. | 2018-02-15 |
| Dromos DR/DR-A and Dromos SR/SR-B Cardiac Pacing System (P950037/S183) | Biotronik, Inc. | 2018-02-15 |
| ENROUTE Transcarotid Stent System (P140026/S008) | Boston Scientific Corporation | 2018-02-14 |
| Micra TPS MC1VR01 (P150033/S030) | Medtronic, Inc. | 2018-02-12 |
| BSC Intella Nav MIFI OI Ablation Cathetrs (P150005/S033) | Boston Scientific Corp | 2018-02-09 |
| IntellaNav St Cardiac Ablation Catheter (P920047/S104) | Boston Scientific Corp | 2018-02-09 |
| Diamond Back 360 Coronary Orbital Atherectomy System (P130005/S019) | Cardiovascular Systems, Inc. | 2018-02-09 |
| 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/S616) | Medtronic Cardiac Rhythm Disease Management | 2018-02-08 |
| VALITUDE CRT-P; VALITUDE X4 CRT-P; VISIONIST (P030005/S173) | Guidant Corp. | 2018-02-08 |
| FINELINE II Lead Family (P960004/S082) | Boston Scientific | 2018-02-08 |
| EMBLEM S-ICD; EMBLEM MRI S-ICD (P110042/S103) | Boston Scientific Corporation | 2018-02-08 |
| ESSENTIO; PROPONENT; ACCOLADE MRI (P150012/S053) | Boston Scientific | 2018-02-08 |
| DYNAGEN X4; INOGEN X4; ORIGEN X4; AUTOGEN X4; MOMENTUM X4; VIGILIANT X4; RESONATE X4/HF; PUNCTUA; ENERGEN; INCEPTA CRT-D (P010012/S478) | Boston Scientific Corp | 2018-02-08 |
| EluNIR™ Ridaforolimus Eluting Coronary Stent System (P170008/S001) | Medinol, Ltd. | 2018-02-08 |
| DYNAGEN EL/MINI; INOGEN EL/MINI; ORIGEN EL/MINI; AUTOGEN EL; VIGILIANT EL; PERCIVA; RESONATE EL/HF; PERCIVA HF; MOMENTUM (P960040/S419) | Boston Scientific | 2018-02-08 |
| Isoflex Low Voltage Lead (P960030/S055) | ABBOTT MEDICAL | 2018-02-08 |
| Flextome Coronary Cutting Balloon (P950020/S088) | Boston Scientific Corp | 2018-02-08 |
| Perceval Sutureless Heart Valve (P150011/S011) | Corcym S.r.l. | 2018-02-08 |
| AngioJet Ultra Thrombectomy System Console (P980037/S068) | Boston Scientific Corp | 2018-02-08 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC (P980016/S656) | Medtronic Cardiac Rhythm Disease Management | 2018-02-08 |
| ACCOLADE; PROPONENT; ESSENTIO; ALTRUA 2 PACEMAKER (N970003/S225) | Boston Scientific Corp | 2018-02-08 |
| Impella 2.5 & Impella CP Systems (P140003/S027) | Abiomed, Inc. | 2018-02-08 |
| Quickflex u and Quartet CRT Leads (P030054/S346) | ABBOTT MEDICAL | 2018-02-08 |
| Tendril and Optisense f Low Voltage Leads (P960013/S094) | ABBOTT MEDICAL | 2018-02-08 |
| AngioJet Ultra Console (P980037/S069) | Boston Scientific Corp | 2018-02-08 |
| Durata and Optisure High Voltage Leads (P950022/S114) | ABBOTT MEDICAL | 2018-02-08 |
| LifeVest Wearable Defibrillator (P010030/S098) | Zoll Manufacturing Corporation | 2018-02-07 |
| Impella Ventricular Support Systems (P140003/S018) | Abiomed, Inc. | 2018-02-07 |
| Coseal Surgical Sealant (P030039/S021) | Baxter Bio Science | 2018-02-07 |
| ZOLL X Series (P160022/S001) | ZOLL Medical Corporation | 2018-02-07 |
| Closer Vascular Sealing System (P150022/S004) | Rex Medical, L.P. | 2018-02-07 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (P130024/S021) | Lutonix | 2018-02-06 |
| Relay Thoracic Stent-Graft with Plus Delivery System (P110038/S017) | Bolton Medical, Inc. | 2018-02-06 |
| Freezor Cardiac Cryoablation Catheter (4-mm tip), Freezor Xtra Surgical Cardiac Cryoablation Device (6-mm tip), Freezor (P020045/S085) | Medtronic Cryocath, LP | 2018-02-06 |
| Fortify Assura (P910023/S401) | ABBOTT MEDICAL | 2018-02-06 |
| Unify Assura, Quadra Assura, Quadra Assura MP (P030054/S345) | ABBOTT MEDICAL | 2018-02-06 |
| Freezor MAX (P100010/S072) | Medtronic Cryocath, LP | 2018-02-06 |
| Tridyne Vascular Sealant (P150016/S011) | Neomend, Inc. | 2018-02-05 |
| Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis (P860057/S173) | Edwards Lifesciences, LLC | 2018-02-03 |
| Edwards Sapien XT Transcatheter Heart Valve (P130009/S084) | Edwards Lifesciences, LLC | 2018-02-03 |
| Edwards Sapien 3 Transcatheter Heart Valve (P140031/S059) | Edwards Lifesciences, LLC | 2018-02-03 |
| Edwards Pericardial Aortic Bioprosthesis (RESILIA tissue) (P150048/S013) | Edwards Lifesciences, LLC | 2018-02-03 |
| EDWARDS INTUITY ELITE Valve System (P150036/S024) | Edwards Lifesciences, LLC | 2018-02-03 |
| NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva) (P960040/S414) | Boston Scientific | 2018-02-02 |
| NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Origen) / NG4 Family of CRT-Ds (Resonate, Vigilant) (P010012/S473) | Boston Scientific Corp | 2018-02-02 |
| ThermoCool SmartTouch Uni-Directional Navigation Catheter (P040036/S060) | Biosense Webster, Inc. | 2018-02-02 |
| Accent MRI Pacemaker (P140033/S018) | ABBOTT MEDICAL | 2018-02-02 |
| Ventak PRx and Ventak Mini AICDs (P910077/S164) | Boston Scientific | 2018-02-02 |
| Ingenio Pacemakers (Advantio, Ingenio, Vitalio, Formio / Ingenio 2 Pacemakers (Altrua 2, Essentio, Proponent, Accolade) (N970003/S223) | Boston Scientific Corp | 2018-02-02 |
| ThermoCool SmartTouch Bi-Directional Navigation Catheter (P030031/S082) | Biosense Webster, Inc. | 2018-02-02 |
| Essentio MRI, Proponent MRI, Accolade MRI Pacemakers (P150012/S051) | Boston Scientific | 2018-02-02 |
| Ingenio CRT-P Devices (Invive, Intua), Ingenio 2 CRT-P Devices (Valitude, Valitude X4, Visiionist, Visionist X4) (P030005/S171) | Guidant Corp. | 2018-02-02 |
| Promote+, Quadra Assura, Unify, Unify Assura, and Unify Quadra (P030054/S347) | ABBOTT MEDICAL | 2018-02-01 |
| Current+, Ellipse, Fortify, Fortify Assura, and Quadra Assura MP (P910023/S402) | ABBOTT MEDICAL | 2018-02-01 |
| Assurity, Assurity+, Endurity, Accent, Identity ADx XL, Sustain XL, Verity ADx XL, Victory XL, and Zephyr XL (P880086/S294) | ABBOTT MEDICAL | 2018-02-01 |
| Allure, Allure Quadra, Quadra Allure MP, Anthem, and Frontier II (P030035/S165) | ABBOTT MEDICAL | 2018-02-01 |
| Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S034) | Medtronic Vascular | 2018-02-01 |
| Lifeline/ReviveR DDU-100, Lifeline/ReviveR AUTO DDU-120, Lifeline/ReviveR VIEW DDU-2300, Lifeline/ReviveR VIEW AUTO DDU- (P160032) | Defibtech, LLC | 2018-02-01 |
| Assurity MRI and Endurity MRI (P140033/S024) | ABBOTT MEDICAL | 2018-02-01 |
| Endurant, Endurant II, Endurant LLs talent Occluder (P100021/S069) | Medtronic Vascular | 2018-02-01 |
| Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, and Evera XT VR ICD (P980016/S649) | Medtronic Cardiac Rhythm Disease Management | 2018-01-31 |
| Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, and Viva XT CRT-D (P010031/S610) | Medtronic Cardiac Rhythm Disease Management | 2018-01-31 |
| Closer Vascular Sealing System (VSS) (P150022/S003) | Rex Medical, L.P. | 2018-01-31 |
| EXCOR Blood Pump (P160035/S003) | Berlin Heart, Inc. | 2018-01-31 |
| Trifecta Heart Valves (P100029/S029) | ABBOTT MEDICAL | 2018-01-30 |
| EDWARDS INTUITY Elite Valve System (P150036/S019) | Edwards Lifesciences, LLC | 2018-01-30 |
| Biocor and Epic Heart Valves (P040021/S034) | ABBOTT MEDICAL | 2018-01-30 |
| Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis, Model 3300TFX (P860057/S169) | Edwards Lifesciences, LLC | 2018-01-30 |
| VenaSeal Closure System (P140018/S008) | Medtronic Vascular, Inc. | 2018-01-30 |
| Edwards Pericardial Aortic Bioprosthesis (P150048/S006) | Edwards Lifesciences, LLC | 2018-01-30 |
| REPLY & ESPRIT SR & DR Pacemakers (P950029/S117) | MicroPort CRM USA, Inc. | 2018-01-29 |
| Reply SR, Reply DR, Esprit SR, Esprit DR (P950029/S119) | MicroPort CRM USA, Inc. | 2018-01-29 |
| Artegraft Collagen Vascular Graft (N16837/S024) | LeMaitre Vascular, Inc. | 2018-01-26 |
| MULTI-LINK 8 Coronary Stent System / SV / LL Coronary Stent System (P020047/S066) | Abbott Vascular | 2018-01-25 |
| XACT Carotid Stent System (P040038/S032) | Abbott Vascular, Inc. | 2018-01-25 |
| Supera Peripheral Stent System (P120020/S017) | Abbott Vascular (Idef Technologies Inc) | 2018-01-25 |
| Cardiac Resynchronization Therapy Defibrillator CRT-Ds (P060027/S092) | MicroPort CRM USA, Inc. | 2018-01-25 |