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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 Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, postosystemic, endoprosthesis
PMA NumberP040027
Supplement NumberS041
Date Received03/04/2015
Decision Date04/03/2015
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the water entry pressure (wep) testing requirement for the graft components of the gore viatorr tips endoprosthesis from a lot acceptance test to a qualification test.