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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.
 
Trade NameZENITH TX2 TAA ENDOVASCULAR GRAFT
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantCOOK, INC.
PMA NumberP070016
Supplement NumberS005
Date Received07/12/2011
Decision Date11/05/2012
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for in-house manufacture of stent graft material.
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