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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 NameENDURANT AND ENDURANT II STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
ApplicantMEDTRONIC
PMA NumberP100021
Supplement NumberS035
Date Received04/15/2014
Decision Date05/13/2014
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 clarifications made to the rear handle assembly manufacturing process procedures.
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