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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 Coronary Stent Graft System
Classification Namecoronary covered stent
Generic Namecoronary covered stent
Applicant
Abbott Vascular Devices
26531 ynez rd.
temecula, CA 92591
HDE NumberH000001
Supplement NumberS027
Date Received09/09/2024
Decision Date09/20/2024
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 
Approval for changing the bacterial endotoxin test method from gel clot to kinetic chromogenic.
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