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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 TX2 TAA ENDOVASCULAR GRAFT
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantWilliam Cook Europe Aps
Sandet 6, Dk-4632
Bjaeverskov 
PMA NumberP070016
Supplement NumberS002
Date Received08/15/2008
Decision Date11/25/2008
Withdrawal Date02/24/2020
Product Code MIH 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR USE OF A MODIFIED INTRODUCTION SYSTEM, THE Z-TRAK PLUS INTRODUCTION SYSTEM, WITH THE ZENITH TX2 TAA ENDOVASCULAR GRAFT.
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