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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 NumberS053
Date Received12/12/2016
Decision Date01/09/2017
Product Code MIR 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Implementation of an alternate laser equipment during manufacturing of the VIATORR TIPS Endoprosthesis and the VIATORR TIPS Endoprosthesis with Controlled Expansion.
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