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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 AAA ENDOVASCULAR GRAFT WITH H&L-B 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 NumberS016
Date Received09/18/2006
Decision Date08/30/2007
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 the addition of alternate vendors for 1) the 5-0 green braided polyester suture and 2) the 5-0 blue monofilament polypropylene suture.
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