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.
Supplier site change.
| 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 | 2017-11-03 |
| Decision Date | 2017-12-13 |
| PMA | P160004 |
| Supplement | S007 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 3250 West Kiltie Lane flagstaff, AZ 86005 |
| 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 |