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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 rd.
temecula, CA 92591
HDE NumberH000001
Supplement NumberS023
Date Received05/15/2023
Decision Date06/14/2023
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 
Alternative sourcing of raw materials for one of the adhesives.
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