Which requested approval to implement changes to your divisional bacterial endotoxin test parameters using the limulus amebocyte lysate test methodology
| 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 | 2019-03-12 |
| Decision Date | 2019-10-02 |
| PMA | P160004 |
| Supplement | S027 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | W. L. GORE & ASSOCIATES, INC. 3250 West Kiltie Lane flagstaff, AZ 86005 |
Supplemental Filings
| 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 |
NIH GUDID Devices