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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
750 daniels way
p.o. box 489
bloomington, IN 47402
PMA NumberP020018
Supplement NumberS034
Date Received03/10/2010
Decision Date03/31/2010
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of manufacturing instructions to assure that the proximal trigger wire is not inadvertently attached to both trigger knobs of the delivery system.