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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.
 
DeviceCOOK ZENITH RENU AAA ANCILLARY GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, IN 47402
PMA NumberP020018
Supplement NumberS008
Date Received01/09/2006
Decision Date02/09/2006
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 modifying the instructions for use (ifu) for the cook zenith. Renu aaa ancillary graft to reinforce the precaution not to inflate the molding balloon in the vessel outside the graft.
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