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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.
 
DeviceZENITH FLEX AAA ENDOVASCULAR GRAFT WITH THE H&LB ONE-SHOT INTRODUCTION SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
COOK, INC.
750 daniels way
p.o. box 489
bloomington, IN 47402
PMA NumberP020018
Supplement NumberS009
Date Received05/01/2006
Decision Date06/01/2006
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the zenith flex aaa endovascular graft ancillary component labeling to clarify the length limitations for use of the 58 mm length main body extension when used in conjunction with the shortest zenith main body components.
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