GORE TIGRIS Vascular Stent

Stent, Superficial Femoral Artery

FDA Premarket Approval P160004 S027

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

Which requested approval to implement changes to your divisional bacterial endotoxin test parameters using the limulus amebocyte lysate test methodology

DeviceGORE TIGRIS Vascular Stent
Classification NameStent, Superficial Femoral Artery
Generic NameStent, Superficial Femoral Artery
ApplicantW. L. GORE & ASSOCIATES, INC.
Date Received2019-03-12
Decision Date2019-10-02
PMAP160004
SupplementS027
Product CodeNIP
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-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

Device IDPMASupp
00733132636396 P160004 000
00733132636235 P160004 000
00733132636228 P160004 000
00733132636211 P160004 000
00733132636204 P160004 000
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00733132636167 P160004 000
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00733132636136 P160004 000
00733132636129 P160004 000
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00733132636259 P160004 000
00733132636389 P160004 000
00733132636372 P160004 000
00733132636365 P160004 000
00733132636358 P160004 000
00733132636341 P160004 000
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00733132636327 P160004 000
00733132636310 P160004 000
00733132636303 P160004 000
00733132636297 P160004 000
00733132636280 P160004 000
00733132636273 P160004 000
00733132636266 P160004 000
00733132636105 P160004 000

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