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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 NameTRIVASCULAR INC OVATION ABDOMINAL STENT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
TRIVASCULAR INC
3910 brickway blvd
santa rosa, CA 95403
HDE NumberH100008
Supplement NumberS001
Date Received12/12/2011
Decision Date04/13/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for an alternate material supplier and a change to the ethylene oxide sterilization process.
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