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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceGORE VIATORR TIPS ENDOPROSTHESIS
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. GORE & ASSOCIATES, INC.
32360 N NORTH VALLEY PARKWAY
PHOENIX, AZ 85085
PMA NumberP040027
Supplement NumberS010
Date Received01/22/2008
Decision Date05/29/2008
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR: 1) A CHANGE IN THE TYPE OF COOLING GAS; 2) A CHANGE IN THE APPLICATION OF THE COOLANT; AND 3) THE ADDITION OF A TEMPERATURE CONTROLLER.
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