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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.
Classification Namesystem, endovascular graft, aortic aneurysm treatment
PMA NumberP020018
Supplement NumberS052
Date Received05/06/2014
Decision Date06/04/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updating your internal quality control for the zenith aaa endovascular graft introduction system subassemblies by adding an additional inspection step to check for security of the tapered tip on the cannula.