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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, portosystemic, endoprosthesis
32360 n north valley parkway
phoenix, AZ 85085
PMA NumberP040027
Supplement NumberS002
Date Received09/19/2005
Decision Date12/08/2005
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change certain manufacturing processes from a manual process to a semi-automated process. The device, as modified, will be marketed under the trade name gore viatorr tips endoprosthesis and is indicated for use in de novo and revision treatment of portal hypertension and its complications such as variceal bleeding, gastropathy, ascites, and/or hepatic hydrothorax.