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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
Device36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantCOOK, INC.
750 Daniels Way
P.O. Box 489
Bloomington, IN 47402
PMA NumberP020018
Supplement NumberS010
Date Received06/02/2006
Decision Date09/07/2006
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE 36 MM DIAMETER ZENITH FLEX AAA ENDOVASCULAR GRAFT.
Post-Approval StudyShow Report Schedule and Study Progress
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