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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, postosystemic, endoprosthesis
PMA NumberP040027
Date Received06/09/2004
Decision Date12/06/2004
Product Code
MIR[ Registered Establishments with MIR ]
Docket Number 06M-0411
Notice Date 10/17/2006
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the gore viatorr tips endoprosthesis. The device 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.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S024 S025 S026 S028 S029 
S030 S031 S032 S033 S034 S035 S036 S037 S038 
S039 S040 S041 S042 S043 S044 S045