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  1. Device Approvals, Denials and Clearances

2019 Device Approvals

The products listed in this section include some of the newest medical technology from the year 2019. 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 2019

Device Name Category Date
HeartStart OnSite Defibrillator (Model M5066A), HeartStart Home Defibrillator (Model M5068A), Primary Battery (Model M5070A), SMART Pads Cartridges (Adult Model M5071A) and Infant/Child (Model M5072A) - P160029 Defibrillator 06/06/19
Eversense Continuous Glucose Monitoring System - P160048/S006 Glucose Monitor 06/06/19
Hintermann Series H3™ Total Ankle Replacement System - P160036 Joint Replacement 06/04/19
TransMedics OCS Lung System - P160013/S002 Lung Donor 05/31/19
The therascreen PIK3CA RGQ PCR Kit - P190001 and P190004 Cancer 05/24/19
NovoTTF™-100L System - H180002 Cancer 05/23/19
Neuroform Atlas® Stent System - P180031 Stent 05/16/19
VICI VENOUS STENT® System - P180013 Stent 05/02/19
Tack Endovascular System® (6F) - P180034 Vascular 05/01/19
XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 Perfusion System 04/26/19
LOTUS Edge™ Valve System - P180029 Heart Valve 04/23/19
TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024 Weight Loss 04/16/19
therascreen® FGFR RGQ PCR Kit – P180043 Laboratory Test 04/12/19
TherOx DownStream System - P170027 Oxygen Therapy 04/02/19
Cerene Cryotherapy Device - P180032 Menstrual Bleeding 03/28/19
TRILURON™ - P180040 Osteoarthritis 03/16/19
OPTIMIZER Smart System - P180036 Cardiovascular 03/21/19
MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System - P100009/S028 Vascular 03/14/19
VENOVO Venous Stent System - P180037 Stent 03/13/19
Barricaid® Anular Closure Device (ACD) - P160050 Cancer 03/11/19
COVERA™ Vascular Covered Stent - P170042/S002 Stent 03/01/19
VENTANA PD-L1 (SP142) Assay - P160002/S009 Hernia 02/08/19
M6-C™ Artificial Cervical Disc - P170036 Spine 02/06/19
MANTA Vascular Closure Device - P180025 Vascular 02/01/19
Sangia Total PSA Test - P170037 Prostate Cancer 01/30/19

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