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  6. 2018 Device Approvals
  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2018. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2018

Device Name



Zenith Dissection Endovascular System - P180001 Artery 12/31/18
Woven EndoBridge (WEB) Aneurysm Embolization System - P170032 Aneurysm 12/31/18
LIFEPAK® CR2 Defibrillator - P170018 Defibrillator 12/21/18
Exablate Model 4000 System - Type 1.0 and 1.1 (Exablate Neuro) P150038/S006 Ultrasound 12/16/18
Resolute Onyx Zotarolimus Eluting Coronary Stent System - P160043/S012 Stent 12/14/18
Pipeline Flex Embolization Device - P100018/S015 Aneurysm 12/14/18
Resolute Integrity Zotarolimus Eluting Coronary Stent System - P110013/S088 Stent 12/14/18
Cardiac Science Powerheart® AED G3 Pro – P160034 Automatic External Defibrillator (AED) 12/07/18
Cardiac Science Powerheart® AED G3, G3 Plus, and G5 – P160033 Automatic External Defibrillator (AED) 12/07/18
Spiration Valve® System - P180007 Emphysema 12/03/18
VASCADE® MVP Venous Vascular Closure System (VVCS) - P120016/S024 Vascular 11/27/18
INCRAFT® AAA Stent Graft System - P150002 Aneurysm 11/27/18
GORE® Carotid Stent – P180010 Carotid Stent 11/01/18
Valiant Navion Thoracic Stent Graft System - P100040/S036 Stent 10/19/18
HeartMate 3 Left Ventricular Assist System (LVAS) - P160054/S008 Heart Pump 10/18/18
VisuMax Femtosecond Laser - P150040/S003 Ophthalmic Surgical Laser 10/04/18
BioMimics 3D Vascular Stent System - P180003 Stent 10/04/18
Eluvia Drug-Eluting Vascular Stent System - P180011 Stent 09/18/18
PK Papyrus Covered Coronary Stent System - H170004 Stent 09/14/18
Visian® Toric ICL (Implantable Collamer® Lens) - P030016/S001 Implantable Lens 09/13/18
PD-L1 IHC 22C3 pharmDx - P150013/S011 Cancer 08/16/18
Hydrus® Microstent - P170034 Intraocular 08/10/18
Edwards Pericardial Mitral Bioprosthesis, Model 11000M - P150048/S012 Artificial Heart Valve 08/09/18
Covera Vascular Covered Stent - P170042 Stent 07/30/18
Magtrace and Sentimag Magnetic Localization System - P160053 Breast Cancer 07/24/18
Freestyle Libre 14 Day Flash Glucose Monitoring System - P160030/S017 Glucose Monitoring 07/23/18
Abbott RealTime IDH1 - P170041 Leukemia 07/20/18
Surpass Streamline Flow Diverter - P170024 Stent 07/13/18
Zephyr® Endobronchial Valve System - P180002 Bronchial Valve 06/29/18
t:slim X2 Insulin Pump with Basal-IQ Technology - P180008 Glucose Monitor 06/21/18
Minimed 670G System - P160017/S031 Glucose Monitor 06/21/18
Eversense Continuous Glucose Montioring System - P160048 Glucose Monitor 06/21/18
iStent inject Trabecular Micro-Bypass System (Model G2-M-IS) -€“ P170043 Stent delivery tool 06/21/18
AUGMENT® Injectable - P100006/S005 Bone Fusion 06/12/18
PD-L1 IHC 22C3 pharmDx - P150013/S009 Cancer 06/12/18
enVista® One Piece Hydrophobic Acrylic Toric Intraocular Lens - P910056/S027 Intraocular Lens 06/08/18
CustomFlexTM Artificial Iris - P170039 Artificial Iris 05/30/18
Restylane Lyft with Lidocaine - P040024/S099 Dermal Filler 05/18/18
SYNOJOYNTTM - P170016 Injection 05/08/18
Bausch + Lomb ULTRA (samfilcon A) Contact Lenses - P170035 Contact Lens 04/30/18
PartoSure test - P160052 PAMG-1 Test 04/30/18
Medtronic DBS System for Epilepsy - P960009/S219 Epilepsy 04/27/18
Medtronic IN.PACTTM AdmiralTM Paclitaxel-Coated PTA Balloon Catheter - P140010/S037 Catheter 04/19/18
ThinPrep Integrated Imager - P950039/S036 Cervical Cancer 04/18/18
AngelMed Guardian System - P150009 Cardiac Monitor 04/09/18
FoundationFocus CDxBRCA LOH - P160018/S001 Ovarian Cancer 04/06/18
GORE® CARDIOFORM Septal Occluder - P050006/S060 Heart Implant 03/30/18
TransMedics, Inc. TransMedics OCS Lung System - P160013 Lung preservation system 03/22/18
LIPOSORBER® LA-15 System - H170002 Cholesterol 03/20/18
Guardian Connect System - P160007 Glucose Monitor 03/08/18
Abbott Perclose ProGlide Suture-Mediated Closure System - P960043/S097 Suture 02/16/18
MiniMed 630G System with SmartGuard - P150001/S021 Glucose Monitor 02/13/18
MiniMed 670G System - P160017/S017 Glucose Monitor 02/13/18
BD Onclarity HPV Assay - P160037 HPV Test 02/12/18
Impella Ventricular Support Systems - P140003/S018 Heart Pump 02/07/18
Lifeline/ReviveR ECG and DDU Automated Defibrillators - P160032 Defibrillators 02/01/18
Aptima HBV Quant assay - P170025 HBV Test 01/28/18



















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