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  6. 2017 Device Approvals
  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2017. 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 2017

Device Name Category Date
Implantable System for Remodulin - P140032 Infusion System 12/22/17
LIFEPAK CR® Plus Defibrillator, LIFEPAK EXPRESS® Defibrillator, and CHARGE-PAK® Battery Charger - P160012 Defibrillator 12/21/17
PREVELEAK Surgical Sealant - P100030/S008 Sealant 12/21/17
HEMOBLAST Bellows - P170012 Hemostasis 12/15/17
Vercise Deep Brain Stimulation (DBS) System - P150031 Neurostimulator 12/08/17
FoundationOne CDx - P170019 Laboratory Test 11/30/17
EluNIR® Ridaforolimus Eluting Coronary Stent System - P170008 Stent 11/28/17
TriVisc - P160057 Osteoarthritis 11/13/17
Cheatham Platinum (CP) Stent System (Covered CP Stent and Covered Mounted CP Stent) - P150028/S001 Stent 10/24/17
RHA® 2, RHA® 3, and RHA® 4 Dermal Fillers - P170002 Dermal Fillers 10/19/17
remedē® System - P160039 Nerve Stimulator 10/06/17
Endurant II/Endurant IIs Stent Graft System - P100021/S063 Stent Graft 09/29/17
HeartWareTM HVADTM - P100047/S090 Heart Pump 09/27/17
PD-L1 IHC 22C3 pharmDx -€“ P150013/S006 Lab Test 09/22/17
Impella RP® System - P170011 Heart Pump 08/23/17
Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010 - P170003 Dialysis 08/25/17
HeartMate 3TM Left Ventricular Assist System - P160054 Heart Pump 08/23/17
Boston Scientific Spinal Cord Stimulation System - P030017/S275 Spinal Cord 08/11/17
Revanesse Ultra - P160042 Dermal Filler 08/04/17
Abbott RealTime IDH2 - P170005 Laboratory Test 08/01/17
PulseRider Aneurysm Neck Reconstruction Device ("PulseRider") - H160002 Aneurysms 06/19/17
Edwards SAPIEN 3 Transcatheter Heart Valve - P140031/S028 Heart Valve 06/05/17
ZOLL® AED Plus® and Fully Automatic AED Plus® - P160015 Defibrillator 05/26/17
ZOLL® X Series®, R Series®, AED Pro®, and AED 3 BLS® Professional Defibrillators - P160022 Defibrillators 05/26/17
Abbott RealTime CMV Assay - P160044 CMV Test 05/18/17
FlourishTM Pediatric Esophageal Atresia Device - H150003 Esophagus Repair 05/12/17
HeartSine samaritan® SAM 350P, SAM 360P, and SAM 450P Public Access Automated External Defibrillators and Accessories -€“ P160008 Defibrillators and Accessories 01/12/17


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