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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, ENDURANT II AORTO-UNI-ILAIAC (AUI) STENT GRAFT SYSTEM
Classification Namesystem, endovascular graft, aortic aneurysm treatment
Applicant MEDTRONIC INC.
PMA NumberP100021
Supplement NumberS040
Date Received09/03/2014
Decision Date10/03/2014
Product Code
MIH[ Registered Establishments with MIH ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate supplier for the secondary and tertiary packaging for endurant and endurant ii stent graft systems. Additionally, a change in configuration for the e-beam sterilization process.
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