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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
Generic NameSHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
ApplicantW. L. Gore & Associates, Inc.
32360 N. N. Valley Pkwy.
Phonix, AZ 85085
PMA NumberP040027
Supplement NumberS009
Date Received12/07/2007
Decision Date04/18/2008
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE ETHYLENE OXIDE STERILIZATION CYCLE.
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