| Maestro 4000 Controller (P920047/S110) | Boston Scientific Corp | 2019-01-28 |
| Maestro 4000 Controller (P020025/S113) | Boston Scientific | 2019-01-28 |
| MetriQ Pump (P150005/S039) | Boston Scientific Corp | 2019-01-28 |
| Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) EMBLEM S-ICD/MRI S-ICD (P110042/S121) | Boston Scientific Corporation | 2019-01-23 |
| Cardiac Resynchronization Therapy Defibrillators (CRT-D) Origen, Inogen, Dynagen, Autogen and Momentum CRT-D (P010012/S495) | Boston Scientific Corp | 2019-01-23 |
| Implantable Cardioverter Defibrillator (ICD) Origen, Inogen, Dynagen, Autogen, Momentum, Vigilant, Resonate and Perciva (P960040/S432) | Boston Scientific | 2019-01-23 |
| Consulta , Syncra and Viva CRT-P (P010015/S389) | Medtronic, Inc. | 2019-01-22 |
| LIFEPAK Automated External Defibrillators (AEDs) (P160026/S005) | Physio-Control, Inc. | 2019-01-22 |
| HeartMate 3 Left Ventricular Assist System (HM3 LVAS) (P160054/S015) | ABBOTT MEDICAL | 2019-01-18 |
| CardioMEMS HF (Heart Failure) System (P100045/S034) | ABBOTT MEDICAL | 2019-01-17 |
| Rebel Platinum Chromium Coronary Stent System (P130030/S058) | Boston Scientific Corp | 2019-01-17 |
| Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (P110010/S161) | Boston Scientific Corp | 2019-01-17 |
| COBRA PzF NanoCoated Coronary Stent System (P160014/S005) | Celonova Biosciences, Inc. | 2019-01-17 |
| Biocor, Biocor Supra, Epic, Epic Supra Valves (P040021/S037) | ABBOTT MEDICAL | 2019-01-17 |
| Angio Seal Vascular Closure Device (P930038/S090) | Terumo Medical Corporation | 2019-01-17 |
| Resolute Onyx Zotarolimus Eluting Coronary Stent System (P160043/S013) | Medtronic Vascular | 2019-01-17 |
| LifeVest Wearable Defibrillator (P010030/S112) | Zoll Manufacturing Corporation | 2019-01-16 |
| AMPLATZER Piccolo Occluder (P020024/S052) | ABBOTT MEDICAL | 2019-01-11 |
| Fineline II Lead Family (P960004/S087) | Boston Scientific | 2019-01-10 |
| Ingevity Lead Family (passive fixation models) (P150012/S069) | Boston Scientific | 2019-01-10 |
| Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP, Therapy C (P110016/S058) | ABBOTT MEDICAL | 2019-01-10 |
| EasyTrak II Lead Family (P010012/S493) | Boston Scientific Corp | 2019-01-10 |
| Therapy Ablation Catheters (P040014/S035) | Irvine Biomedical, Inc. | 2019-01-10 |
| Innova Vascular Self-Expanding Stent System (P140028/S036) | Boston Scientific Corporation | 2019-01-10 |
| Rotapro Rotational Atherectomy System (P900056/S174) | Boston Scientific Corp | 2019-01-10 |
| Livewire TC Steerable Electrophysiology Catheter, Safire Bi-Directional Ablation Catheter (P960016/S076) | St Jude Medical | 2019-01-10 |
| CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION (P010031/S657) | Medtronic Cardiac Rhythm Disease Management | 2019-01-10 |
| Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators (P040042/S041) | Irvine Biomedical,Inc.(Ibi) | 2019-01-10 |
| Therapy Cool Path, Safire BLU, Safire BLU SP, Therapy Cool Path SP, 1500T9-CP RF Generators (P060019/S044) | Irvine Biomedical, Inc. | 2019-01-10 |
| TactiCath Quartz Set (P130026/S037) | St Jude Medical | 2019-01-10 |
| AngioJet Rheolytic Thrombectomy System (P980037/S072) | Boston Scientific Corp | 2019-01-10 |
| Reliance 4-Front Lead Family (passive fixation models) (P910073/S152) | Boston Scientific | 2019-01-10 |
| Programmer Recorder Monitor (PRM) for Implantable Pulse Generators, Model 3300 LATITUDE Programming System, Model 6395 I (P910077/S167) | Boston Scientific | 2019-01-09 |
| 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/S650) | Medtronic Cardiac Rhythm Disease Management | 2019-01-09 |
| Blazer OI, IntellaNav OI, IntellaTip MiFi OI, and IntellaNav MiFi OI (P150005/S041) | Boston Scientific Corp | 2019-01-09 |
| IntellaNav ST (P920047/S112) | Boston Scientific Corp | 2019-01-09 |
| 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/S692) | Medtronic Cardiac Rhythm Disease Management | 2019-01-09 |
| Impella CP System (P140003/S028) | Abiomed, Inc. | 2019-01-09 |
| IntellaNav XP and MiFI XP (P020025/S115) | Boston Scientific | 2019-01-09 |
| Syncardia Temporary Total Artificial Heart (TAH-T) system (P030011/S066) | Syncardia Systems, LLC | 2019-01-09 |
| Amplatzer Duct Occluder/Amplatzer Duct Occluder II (P020024/S053) | ABBOTT MEDICAL | 2019-01-08 |
| Amplatzer PFO Occluder (P120021/S009) | ABBOTT MEDICAL | 2019-01-08 |
| HeartMate 3 Left Ventricular Assist System (P160054/S016) | ABBOTT MEDICAL | 2019-01-08 |
| Perceval Heart Valve (P150011/S014) | Corcym S.r.l. | 2019-01-08 |
| Amplatzer Septal Occluder/Amplatzer Cribriform Occluder (P000039/S063) | ABBOTT MEDICAL | 2019-01-08 |
| Amplatzer Muscular VSD Occluder (P040040/S034) | ABBOTT MEDICAL | 2019-01-08 |
| LifeVest Wearable Defibrilator (P010030/S110) | Zoll Manufacturing Corporation | 2019-01-07 |
| Advisa DR, DR MRI and SR MRI IPG (P980035/S574) | Medtronic, Inc. | 2019-01-07 |
| Consulta CRT-P, Syncra CRT-P, and Viva CRT-P (P010015/S388) | Medtronic, Inc. | 2019-01-07 |
| Impella 2.5, Impella CP, Impella CP with SmartAssist, Impella 5.0, and Impella LD Systems (P140003/S045) | Abiomed, Inc. | 2019-01-07 |
| Enhancements to Software Model 9986 version 2.11.1 and Model SW028 to version 8.2.1 (P890003/S401) | Medtronic, Inc. | 2019-01-07 |
| CARDIOMEMS HF SYSTEM (P100045/S007) | ABBOTT MEDICAL | 2019-01-04 |
| Bioglue Surgical Adhesive (P010003/S032) | Cryolife, Inc. | 2019-01-04 |
| IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (P140010/S042) | Medtronic, Inc. | 2019-01-04 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030054/S356) | ABBOTT MEDICAL | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P960013/S099) | ABBOTT MEDICAL | 2019-01-03 |
| GORE VIABAHN Endoprosthesis (P040037/S105) | W. L. Gore & Associates, Inc. | 2019-01-03 |
| Arctic Front Advance Pro Cardiac Cryoablation Catheter (P100010/S087) | Medtronic Cryocath, LP | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P140033/S034) | ABBOTT MEDICAL | 2019-01-03 |
| Quadra Allure/ Quadra Allure MP Cardiac Resynchronization Therapy-Pacemaker (CRT-Ps) (P030035/S171) | ABBOTT MEDICAL | 2019-01-03 |
| GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface (P130006/S044) | W. L. Gore & Associates, Inc. | 2019-01-03 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface (P040037/S125) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE TAG Thoracic Endoprosthesis (P040043/S108) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE VIATORR TIPS Endoprosthesis (P040027/S069) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin BIoactive Surface (P130006/S064) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| EXCLUDER AAA Endoprosthesis (P020004/S162) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE CARDIOFORM Septal Occluder (P050006/S072) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| GORE TIGRIS Vascular Stent (P160004/S024) | W. L. Gore & Associates, Inc. | 2019-01-02 |
| Zenith Dissection Endovascular System (P180001) | William Cook Europe Aps | 2018-12-31 |
| Synergy Ablation System (P100046/S009) | AtriCure, Inc. | 2018-12-31 |
| Edwards Pericardial Aortic Bioprosthesis and INSPIRIS RESILIA Aortic Valve (P150048/S023) | Edwards Lifesciences, LLC | 2018-12-28 |
| TactiCath Contact Force Ablation Catheter, Sensor Enabled (P130026/S036) | St Jude Medical | 2018-12-27 |
| Perclose ProGlide Suture-Mediated Closure System (P960043/S103) | Abbott Vascular, Inc. | 2018-12-27 |
| Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (P140031/S074) | Edwards Lifesciences, LLC | 2018-12-27 |
| Wallstent (Tips) Endoprosthesis with Unistep Plus Delivery System (P930031/S061) | Boston Scientific Corp | 2018-12-21 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S052) | Boston Scientific Scimed, Inc. | 2018-12-21 |
| Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System (P980033/S051) | Boston Scientific Corporation | 2018-12-21 |
| LIFEPAK® CR2 Defibrillator (P170018) | Physio-Control, Inc. | 2018-12-21 |
| Powerheart G5 AED (P160033/S001) | ZOLL Medical Corporation | 2018-12-20 |
| LifeStream Balloon Expandable Vascular Covered Stent (P160024/S006) | Bard Peripheral Vascular, Inc. | 2018-12-20 |
| Cordis S.M.A.R.T. CONTROL Nitinol Stent System (P020036/S039) | Cordis US Corporation | 2018-12-20 |
| SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM (P150003/S045) | Boston Scientific Corporation | 2018-12-20 |
| Wolverine Coronary Cutting Balloon (P950020/S092) | Boston Scientific Corp | 2018-12-20 |
| Resolute Integrity Zotarolimus-Eluting Coronary Stent System (P110013/S091) | Medtronic Vascular | 2018-12-20 |
| Enroute Transcarotid Stent System (P140026/S011) | Boston Scientific Corporation | 2018-12-20 |
| REBEL Platinum Chromium Coronary Stent System (P130030/S057) | Boston Scientific Corp | 2018-12-20 |
| Zilver PTX Drug-Eluting Peripheral Stent (P100022/S030) | Cook Ireland, Ltd. | 2018-12-20 |
| Cordis S.M.A.R.T. CONTROL/S.M.A.R.T. Vascular Stent System (P120002/S014) | Cordis US Corporation | 2018-12-20 |
| Cordis PRECISE PRO Rx Nitinol Stent System (P030047/S036) | Cordis US Corporation | 2018-12-20 |
| Accessory to Defibrillator, Automatic Implantable Cardioverter, with Cardiac Resynchronization (CRT-D) (P050023/S116) | Biotronik, Inc. | 2018-12-19 |
| Pulse Generator, Pacemaker, Implatable, with Cardiac Resynchronization (CRT-P), Drug Eluting Permanent Left Ventricular (P070008/S090) | Biotronik, Inc. | 2018-12-19 |
| Pulse Generator, Permanent Implantable, Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Ele (P950037/S186) | Biotronik, Inc. | 2018-12-19 |
| GORE Conformable TAG Thoracic Endoprosthesis (P040043/S107) | W. L. Gore & Associates, Inc. | 2018-12-18 |
| Lutonix 018 Drug Coated Balloon PTA Catheter (P170003/S004) | Lutonix | 2018-12-18 |
| Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB) (P130024/S025) | Lutonix | 2018-12-18 |
| Tendril MRI Low Voltage Active (P140033/S044) | ABBOTT MEDICAL | 2018-12-17 |
| CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead (P930039/S195) | Medtronic, Inc. | 2018-12-17 |
| CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead (P830061/S166) | Medtronic Cardiac Rhythm Disease Management | 2018-12-17 |
| SynCardia temporaty Total Artificial Heart (TAH-t) System (P030011/S065) | Syncardia Systems, LLC | 2018-12-17 |
| Wallstent Iliac Endoprosthesis with Unistep Plus Delivery System (P940019/S053) | Boston Scientific Scimed, Inc. | 2018-12-17 |