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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 NumberS032
Date Received02/23/2009
Decision Date04/02/2009
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE TOP CAP TRIGGER WIRE, DELIVERY SYSTEM POSITIONER, AND TRIGGER KNOB SET SCREW.
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