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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 NumberS010
Date Received01/22/2008
Decision Date05/29/2008
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
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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