• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
3250 west kiltie lane
flagstaff, AZ 86005
PMA NumberP160004
Date Received02/01/2016
Decision Date07/27/2016
Product Code
NIP[ Registered Establishments with NIP ]
Docket Number 16M-2332
Notice Date 08/05/2016
Advisory Committee Cardiovascular
Clinical Trials NCT01576055
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020