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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 PMA to get an up-to-date view of this device.
 
DeviceTRIVASCULAR,INC OVATION AND OVATION PRIME ABDOMINAL STENT GRAFT 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
PMA NumberP120006
Supplement NumberS011
Date Received02/24/2014
Decision Date03/20/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Extension of the hold time of stretched film in the manufacture of theretaining wrap.
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