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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
Trade NameGRAFTMASTER RX Coronary Stent Graft System
Classification Namecoronary covered stent
Generic Namecoronary covered stent
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Supplement NumberS015
Date Received09/28/2017
Decision Date01/25/2018
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
To change the ethylene oxide (eo) sterilization release process for the affected products from using the traditional method of biological indicator testing to a parametric release process.