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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.
 
Trade NameZENITH FLEX AAA ENDOVASCULAR GRAFT, ZENITH RENU AAA ANCILLARY GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK, INC.
PMA NumberP020018
Supplement NumberS030
Date Received11/24/2008
Decision Date12/19/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a contract manufacturer in the construction of subassembly components.
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