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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, ZENITH RENU AAA ANCILLARY GRAFT, ZENITH FENESTRATED 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 NumberS053
Date Received09/22/2014
Decision Date10/21/2014
Product Code MIH 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ALTERNATE METHOD TO SEAL THE STENT GRAFT FABRIC EDGES.
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