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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 NumberS017
Date Received01/26/2018
Decision Date02/21/2018
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
To change the time point when pyrogen testing for ethylene oxide (eo) sterilized products is conducted for products manufactured at its facility located in clonmel, ireland.