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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 VIABAHN VBX Balloon Expandable Endoprosthesis
Generic NameIliac covered stent, arterial
ApplicantW. L. Gore & Associates, Inc.
3250 W. Kiltie Ln.
Flagstaff, AZ 86005
PMA NumberP160021
Supplement NumberS016
Date Received11/21/2018
Decision Date04/09/2019
Product Code PRL 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for new device inspection equipment and modified stent profile acceptance criteria.
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