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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 ENDOPROTHESIS
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 NumberS007
Date Received09/12/2007
Decision Date04/11/2008
Product Code
MIR[ Registered Establishments with MIR ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR MRI CONDITIONAL LABELING FOR 1.5 AND 3.0 TESLA MR SYSTEMS.
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