GORE VIABAHN VBX Balloon Expandable Endoprosthesis

FDA Premarket Approval P160021 S025

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.

Pre-market Approval Supplement Details

Changing an analytical testing laboratory site

DeviceGORE VIABAHN VBX Balloon Expandable Endoprosthesis
Generic NameIliac Covered Stent, Arterial
ApplicantW. L. Gore & Associates, Inc.
Date Received2020-01-03
Decision Date2020-01-23
PMAP160021
SupplementS025
Product CodePRL 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address W. L. Gore & Associates, Inc. 3250 West Kiltie Lane flagstaff, AZ 86005

Supplemental Filings

Supplement NumberDateSupplement Type
P160021Original Filing
S025 2020-01-03 30-day Notice
S024
S023 2019-06-07 Normal 180 Day Track No User Fee
S022 2019-04-26 30-day Notice
S021 2019-04-15 30-day Notice
S020
S019 2019-03-01 30-day Notice
S018 2019-03-01 30-day Notice
S017 2019-02-04 30-day Notice
S016
S015 2018-11-15 30-day Notice
S014 2018-09-18 30-day Notice
S013 2018-08-24 30-day Notice
S012 2018-07-26 30-day Notice
S011 2018-06-29 30-day Notice
S010 2018-06-07 30-day Notice
S009 2018-05-25 30-day Notice
S008 2018-05-03 30-day Notice
S007
S006 2018-04-17 30-day Notice
S005 2018-02-01 30-day Notice
S004 2017-07-17 30-day Notice
S003 2017-07-05 30-day Notice
S002 2017-05-26 30-day Notice
S001

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