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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 NumberS025
Date Received06/05/2024
Decision Date07/02/2024
Product Code
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 
A change to the data-based process monitoring approach.
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