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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
Classification Nameshunt, portosystemic, endoprosthesis
Generic Nameshunt, portosystemic, endoprosthesis
Applicant
W. L. GORE & ASSOCIATES, INC.
32360 n north valley parkway
phoenix, AZ 85085
PMA NumberP040027
Supplement NumberS018
Date Received10/23/2009
Decision Date11/20/2009
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITIONAL PACKAGING EQUIPMENT.
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