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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 NameGORE VIATORR TIPS ENDOPROSTHESIS
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, postosystemic, endoprosthesis
ApplicantW.L. GORE & ASSOCIATES,INC
PMA NumberP040027
Supplement NumberS040
Date Received02/18/2015
Decision Date03/20/2015
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 
Use of an eptfe bonding film made from an alternate resin and the use of fep film from an alternate supplier.
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