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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
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK, INC.
PMA NumberP020018
Supplement NumberS026
Date Received03/03/2008
Decision Date07/09/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use of the new z-trak introduction system with the zenith flex aaa endovascular graft, to modify the iliac leg component of the zenith flex aaa endovascular graft, and to change the packaging for the main body and iliac leg grafts.
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