| Micra TPS (P150033/S040) | Medtronic, Inc. | 2018-09-05 |
| Consulta CRT-P; Syncra CRT-P; Viva CRT-P (P010015/S377) | Medtronic, Inc. | 2018-09-05 |
| Protecta ICD, Protecta VR ICD, and Protecta XT ICD (P980016/S684) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| EMBLEM S-ICD & EMBLEM MRI S-ICD (P110042/S113) | Boston Scientific Corporation | 2018-09-05 |
| Edwards SAPIEN 3 Transcatheter Heart Valves (P140031/S072) | Edwards Lifesciences, LLC | 2018-09-05 |
| 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/S642) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| Adapta, Versa, Sensia IPG; Astra XT DR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Attesta DR (P980035/S560) | Medtronic, Inc. | 2018-09-05 |
| Edwards SAPIEN XT Transcatheter Heart Valves (P130009/S093) | Edwards Lifesciences, LLC | 2018-09-05 |
| Protecta CRT-D and Protectea XT CRT-D (P010031/S643) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC (P980016/S683) | Medtronic Cardiac Rhythm Disease Management | 2018-09-05 |
| Dynagen Mini ICD, Inogen Mini/EL ICD, Origen Mini/EL ICD, Dynagen EL ICD, Autogen EL ICD, Vigilant EL ICD, Perciva ICD, (P960040/S428) | Boston Scientific | 2018-09-04 |
| nGEN Pump (P990071/S037) | Biosense Webster, Inc. | 2018-09-04 |
| Dynagen CRT-D, Dynagen X4 CRT-D, Inogen CRT-D, Inogen X4 CRT-D, Origen CRT-D, Origen X4 CRT-D, Autogen CRT-D, Autogen X4 (P010012/S489) | Boston Scientific Corp | 2018-09-04 |
| Emblem S-ICD, Emblem MRI S-ICD (P110042/S112) | Boston Scientific Corporation | 2018-09-04 |
| ZOLL R Series Device (P160022/S006) | ZOLL Medical Corporation | 2018-09-03 |
| XIENCE Xpedition RX/OTW, Apline RX/OTW and Sierra RX Everolimus ELuting Coronary Stent System (P110019/S101) | Abbott Vascular | 2018-08-31 |
| Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG (P980035/S559) | Medtronic, Inc. | 2018-08-31 |
| SYNERGY Everolimus-Eluting Platinum Chrominum Coronary Stent System (P150003/S036) | Boston Scientific Corporation | 2018-08-30 |
| PROMUS PREMIER Everolimus-Eluting Platinum Chrominum Coronary Stent System (P110010/S151) | Boston Scientific Corp | 2018-08-30 |
| ZILVER PTX Drug-Eluting Peripheral Stent. (P100022/S028) | Cook Ireland, Ltd. | 2018-08-29 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S022) | Lutonix | 2018-08-29 |
| Livewire TC Ablation Catheter (P960016/S075) | St Jude Medical | 2018-08-28 |
| Impella 2.5, Impella CP, Impella 5.0 and Impella LD (P140003/S038) | Abiomed, Inc. | 2018-08-28 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P070008/S096) | Biotronik, Inc. | 2018-08-27 |
| LifeStent 5F Vascular Stent System (P070014/S058) | Bard Peripheral Vascular, Inc. | 2018-08-27 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P050023/S123) | Biotronik, Inc. | 2018-08-27 |
| Covera Vascular Covered Stent (P170042/S001) | C.R. Bard, Inc. | 2018-08-27 |
| Siello T 53; Siello T 60; Siello JT 45; Siello JT 53; Solia T 53; Solia T 60; Solia JT 45; Solia JT 53 (P950037/S194) | Biotronik, Inc. | 2018-08-27 |
| CoreValve Evolut R System and CoreValve Evolut PRO System (P130021/S051) | Medtronic, Inc. | 2018-08-24 |
| HeartMate 3 Left Ventricular Assist System (LVAS) (P160054/S005) | ABBOTT MEDICAL | 2018-08-24 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S058) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S029) | Cook Ireland, Ltd. | 2018-08-23 |
| EluNIR Ridaforolimus Eluting Coronary Stent System (P170008/S008) | Medinol, Ltd. | 2018-08-23 |
| XIENCE Xpedition, XIENCE Xpedition SV, XIENCE Xpedition LL Everolimus Eluting Coronary Stent Systems (P110019/S099) | Abbott Vascular | 2018-08-23 |
| GORE TIGRIS Vascular Stent (P160004/S018) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| GORE VIABAHN Endoprostheis (P040037/S119) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| GORE VIABAHN VBX Balloon Expandable Endoprosthesis (P160021/S012) | W. L. Gore & Associates, Inc. | 2018-08-23 |
| LifeVest Wearable Defibrillator (P010030/S108) | Zoll Manufacturing Corporation | 2018-08-23 |
| Astron Pulsar and Pulsar-18 Stent Systems (P160025/S005) | Biotronik AG | 2018-08-22 |
| SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (P150003/S041) | Boston Scientific Corporation | 2018-08-22 |
| Impella CP with SmartAssist; Impella 2.5/5.0 LD; Impella CP; Impella LD (P140003/S037) | Abiomed, Inc. | 2018-08-22 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S053) | Boston Scientific Corp | 2018-08-22 |
| Impella RP (P170011/S007) | Abiomed, Inc. | 2018-08-22 |
| SAPIEN 3 Transcatheter Heart Valve (23mm, 26mm, and 29mm (P140031/S073) | Edwards Lifesciences, LLC | 2018-08-22 |
| MANAGE HF Study (P960040/S426) | Boston Scientific | 2018-08-21 |
| MANAGE HF Study (P010012/S486) | Boston Scientific Corp | 2018-08-21 |
| GORE TIGRIS Vascular Stent (P160004/S019) | W. L. Gore & Associates, Inc. | 2018-08-21 |
| Longitudinal Surveillance Registry of the ACUITY Spiral Lead (P010012/S487) | Boston Scientific Corp | 2018-08-20 |
| 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/S641) | Medtronic Cardiac Rhythm Disease Management | 2018-08-16 |
| Enroute Transcarotid Stent System (P140026/S010) | Boston Scientific Corporation | 2018-08-16 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S682) | Medtronic Cardiac Rhythm Disease Management | 2018-08-16 |
| PSW 1801.U (P000009/S076) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P070008/S092) | Biotronik, Inc. | 2018-08-15 |
| Edwards Pericardial Aortic Bioprosthesis / Edwards Inspiris Resilia Aortic Valve (P150048/S025) | Edwards Lifesciences, LLC | 2018-08-15 |
| PSW 1801.U (P050023/S119) | Biotronik, Inc. | 2018-08-15 |
| PSW 1801.U (P950037/S190) | Biotronik, Inc. | 2018-08-15 |
| Angio Seal Vascular Closure Device (P930038/S089) | Terumo Medical Corporation | 2018-08-15 |
| Anthem; Allure, Allure Quadra; Quadra Allure MP (P030035/S172) | ABBOTT MEDICAL | 2018-08-14 |
| SLS ll/GlideLight Catheters (P960042/S063) | Spectranetics (Philips) | 2018-08-14 |
| Assurity MRI; Endurity MRI; Tendril MRI (P140033/S036) | ABBOTT MEDICAL | 2018-08-14 |
| Current+; Fortify; Fortify Assura; Fortify Assura (MR Conditional); Ellipse; Ellipse (MR Conditional) (P910023/S411) | ABBOTT MEDICAL | 2018-08-14 |
| CardioMEMS HF System (P100045/S031) | ABBOTT MEDICAL | 2018-08-14 |
| Promote+; Unify; Unify Quadra; Unify Assura; Quadra Assura; Quadra Assura (MR Conditional); Quadra Assura MP; Quadra Ass (P030054/S358) | ABBOTT MEDICAL | 2018-08-14 |
| Microny (P970013/S078) | ABBOTT MEDICAL | 2018-08-14 |
| Victory; Zephyr; Accent; Assurity; Assurity+; Endurity; Identity XL, Identity ADx XL; Verity ADxXL (P880086/S301) | ABBOTT MEDICAL | 2018-08-14 |
| AngelMed Guardian System (P150009/S001) | Avertix Medical, Inc. | 2018-08-14 |
| ELCA Coronary Atherectomy Catheters (P910001/S105) | Spectranetics Corp. | 2018-08-14 |
| HeartWare Left Ventricular Assist System (P100047/S122) | Medtronic | 2018-08-13 |
| MitraClip System (NT) (P100009/S026) | ABBOTT MEDICAL | 2018-08-13 |
| CoreValve Evolut R System, CoreValve Evolut R XL System and CoreValve Evolut PRO System (P130021/S052) | Medtronic, Inc. | 2018-08-12 |
| Protecta CRT-D, Protecta XT CRT-D (P010031/S637) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| CryoConsole (P020045/S089) | Medtronic Cryocath, LP | 2018-08-10 |
| HeartWare Ventricular Assist System (P100047/S126) | Medtronic | 2018-08-10 |
| TRIDYNE VASCULAR SEALANT; TRIDYNE VS Standard Spray Tips; TRIDYNE VS 6 Extended Spray Tip (P150016/S009) | Neomend, Inc. | 2018-08-10 |
| Impella RP (P170011/S006) | Abiomed, Inc. | 2018-08-10 |
| Protecta ICD, Protecta VR/XT ICD (P980016/S677) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| 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/S639) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M (P980016/S680) | Medtronic Cardiac Rhythm Disease Management | 2018-08-10 |
| S 75-G OTW; S 75-K OTW; S 85-G OTW; S 85-K OTW (P050023/S122) | Biotronik, Inc. | 2018-08-09 |
| EXOSEAL Vascular Closure Device (P100013/S017) | Cordis US Corporation | 2018-08-09 |
| EFH-16; S60-K; S 60-J; S 60-S (P820076/S028) | Biotronik, Inc. | 2018-08-09 |
| Corox OTW BP; Corox OTW-L BP; Corox ProMRI OTW BP; Sentus ProMRI OTW QP S; Sentus ProMRI OTW QP S-xx/49; Corox OTW-S BP; (P070008/S095) | Biotronik, Inc. | 2018-08-09 |
| Edwards Pericardial Mitral Bioprosthesis, Model 11000M (P150048/S012) | Edwards Lifesciences, LLC | 2018-08-09 |
| AFX Endovascular AAA System (P040002/S061) | Endologix, LLC | 2018-08-09 |
| Astron Pulsar/Pulsar-18 Stent Systems (P160025/S006) | Biotronik AG | 2018-08-09 |
| Protego SD; Protego TD; Protego DF-1 SD; Protego ProMRI SDx; Protego DF-1; ProMRI SD; Plexa SD; Plexa ProMRI SD; Plexa D (P980023/S086) | Biotronik, Inc. | 2018-08-09 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S005) | Bard Peripheral Vascular, Inc. | 2018-08-09 |
| Selox ST/JT; Siello S; Solia S; Setrox S; Safio S; S 45-K/53-K; DH; DH IS-1/DF4; EFH-6F-W; S53-K; S 45-S; S 53-S; S 45-F (P950037/S193) | Biotronik, Inc. | 2018-08-09 |
| Carbomedics Prosthetic Heart Valve (CPHV) (P900060/S059) | Corcym S.r.l. | 2018-08-07 |
| Arctic Front Advance Cardiac CryoAblation Catheters (P100010/S081) | Medtronic Cryocath, LP | 2018-08-07 |
| LIFEPAK 15 Monitor/Defibrillator (P160026/S001) | Physio-Control, Inc. | 2018-08-06 |
| HeartMate 3 Left Ventricular Assist System pump rotor sub-assembly (P160054/S004) | ABBOTT MEDICAL | 2018-08-06 |
| LifeStent 5F Vascular Stent System (P070014/S057) | Bard Peripheral Vascular, Inc. | 2018-08-06 |
| HeartWare HVAD System (P100047/S124) | Medtronic | 2018-08-06 |
| Zoll X Series Device (P160022/S005) | ZOLL Medical Corporation | 2018-08-03 |
| WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (P010030/S091) | Zoll Manufacturing Corporation | 2018-08-03 |
| GORE TIGRIS Vascular Stent (P160004/S017) | W. L. Gore & Associates, Inc. | 2018-08-03 |
| Avalus Bioprosthesis (P170006/S006) | Medtronic, Inc. | 2018-08-02 |
| Absolute Pro Vascular Self-Expanding Stent System (P110028/S019) | Abbott Vascular, Inc. | 2018-08-01 |
| Blazer Open-Irrigated and IntellaNav Open-Irrgated Ablation Catheters (P150005/S035) | Boston Scientific Corp | 2018-08-01 |