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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceGORE TIGRIS VASCULAR STENT
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantW. L. GORE & ASSOCIATES, INC.
3250 WEST KILTIE LANE
FLAGSTAFF, AZ 86005
PMA NumberP160004
Date Received02/01/2016
Decision Date07/27/2016
Withdrawal Date 02/07/2020
Product Code NIP 
Docket Number 16M-2332
Notice Date 08/05/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT01576055
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the GORE TIGRIS Vascular Stent. This device is intended to improve luminal diameter in patients with symptomatic de-novo or restenotic lesions or occlusions in the native superficial femoral artery (SFA) and proximal popliteal artery (PPA) with reference vessel diameters ranging from 4.0-6.5 mm and lesion lengths up to 240 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S005 S002 S001 S007 S014 S015 S016 S017 S011 S012 S013 
S004 S008 S025 S026 S027 S022 S006 S009 S018 S019 S028 S024 
S029 S023 S020 S021 
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