GORE TIGRIS Vascular Stent

FDA Premarket Approval P160004 S029

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 TIGRIS Vascular Stent
Generic NameStent, Superficial Femoral Artery
ApplicantW. L. GORE & ASSOCIATES, INC.
Date Received2020-01-03
Decision Date2020-01-23
PMAP160004
SupplementS029
Product CodeNIP 
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
P160004Original Filing
S029 2020-01-03 30-day Notice
S028 2019-04-15 30-day Notice
S027 2019-03-12 135 Review Track For 30-day Notice
S026 2019-03-01 30-day Notice
S025 2019-02-04 30-day Notice
S024 2018-12-07 30-day Notice
S023 2018-11-15 30-day Notice
S022 2018-09-27 30-day Notice
S021 2018-09-18 30-day Notice
S020 2018-08-24 30-day Notice
S019 2018-07-27 30-day Notice
S018 2018-07-26 30-day Notice
S017 2018-07-05 30-day Notice
S016 2018-06-29 30-day Notice
S015 2018-06-27 Special (immediate Track)
S014 2018-06-07 30-day Notice
S013 2018-06-01 30-day Notice
S012 2018-05-25 30-day Notice
S011 2018-05-03 30-day Notice
S010
S009 2018-04-17 30-day Notice
S008 2018-02-07 Normal 180 Day Track No User Fee
S007 2017-11-03 30-day Notice
S006 2017-09-05 30-day Notice
S005 2017-07-05 30-day Notice
S004 2017-05-26 30-day Notice
S003
S002 2016-11-16 30-day Notice
S001 2016-09-09 30-day Notice

NIH GUDID Devices

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