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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
Applicant
ABBOTT VASCULAR DEVICES
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Supplement NumberS024
Date Received12/18/2023
Decision Date01/17/2024
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 
New ehtylene oxide sterilization processing parameter specifications in chamber 8 at sterigenics los angeles.
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