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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 Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR DEVICES
26531 ynez road
temecula, CA 92591
HDE NumberH000001
Supplement NumberS011
Date Received04/14/2014
Decision Date05/13/2014
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Addition of receiving inspection and testing activities of raw materials and supply items at the clonmel, ireland facility and contract laboratories.
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