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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 ENDOVASCULAR GRAFT
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 NumberS025
Date Received01/22/2008
Decision Date06/19/2008
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change from an oxyfume blend ethylene oxide (eto) sterilant to the use of 100% eto sterilant in the current sterilization cycle for the zenith family of devices and the addition of a supplier of the sterilant.
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