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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 NameGRAFT MASTER RX CORONARY STENT GRAFT SYSTM
Classification Namecoronary covered stent
Generic Namecoronary covered stent
Applicant
Abbott Vascular Devices
26531 ynez rd.
temecula, CA 92591
HDE NumberH000001
Supplement NumberS014
Date Received12/06/2016
Decision Date02/17/2017
Product Code
NIV[ Registered Establishments with NIV ]
Advisory Committee Cardiovascular
Clinical Trials NCT01435031
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for updates to the device labeling.
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