Implementation of an alternate machine for use in nitinol wire manufacturing for the following devices: gore excluder aaa endoprosthesis, gore viatorr tips endoprosthesis, gore tag thoracic endoprosthesis, gore viabahn endoprosthesis and gore viabahn endoprosthesis with heparin bioactive surface, gore tigris vascular stent and gore cardioform septal occluder.
| 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 | 2018-12-07 |
| Decision Date | 2019-01-02 |
| PMA | P160004 |
| Supplement | S024 |
| Product Code | NIP |
| Advisory Committee | Cardiovascular |
| Supplement Type | 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