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.
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.
| Device | GORE TIGRIS VASCULAR STENT |
| Classification Name | Stent, Superficial Femoral Artery |
| Generic Name | Stent, Superficial Femoral Artery |
| Applicant | W. L. GORE & ASSOCIATES, INC. |
| Date Received | 2016-02-01 |
| Decision Date | 2016-07-27 |
| Notice Date | 2016-08-05 |
| PMA | P160004 |
| Supplement | S |
| Product Code | NIP |
| Docket Number | 16M-2332 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 3250 West Kiltie Lane flagstaff, AZ 86005 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160004 | Original 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00733132636396 | P160004 | 000 |
| 00733132636235 | P160004 | 000 |
| 00733132636228 | P160004 | 000 |
| 00733132636211 | P160004 | 000 |
| 00733132636204 | P160004 | 000 |
| 00733132636198 | P160004 | 000 |
| 00733132636181 | P160004 | 000 |
| 00733132636174 | P160004 | 000 |
| 00733132636167 | P160004 | 000 |
| 00733132636150 | P160004 | 000 |
| 00733132636143 | P160004 | 000 |
| 00733132636136 | P160004 | 000 |
| 00733132636129 | P160004 | 000 |
| 00733132636112 | P160004 | 000 |
| 00733132636242 | P160004 | 000 |
| 00733132636259 | P160004 | 000 |
| 00733132636389 | P160004 | 000 |
| 00733132636372 | P160004 | 000 |
| 00733132636365 | P160004 | 000 |
| 00733132636358 | P160004 | 000 |
| 00733132636341 | P160004 | 000 |
| 00733132636334 | P160004 | 000 |
| 00733132636327 | P160004 | 000 |
| 00733132636310 | P160004 | 000 |
| 00733132636303 | P160004 | 000 |
| 00733132636297 | P160004 | 000 |
| 00733132636280 | P160004 | 000 |
| 00733132636273 | P160004 | 000 |
| 00733132636266 | P160004 | 000 |
| 00733132636105 | P160004 | 000 |