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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.
 
DeviceZENITH 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 NumberS026
Date Received03/03/2008
Decision Date07/09/2008
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 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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