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.
To expand the manufacturing operations for a cleanroom
| Device | GORE VIABAHN VBX Balloon Expandable Endoprosthesis Manufacturing Expansion |
| Classification Name | Iliac Covered Stent, Arterial |
| Generic Name | Iliac Covered Stent, Arterial |
| Applicant | W. L. Gore & Associates, Inc. |
| Date Received | 2019-03-01 |
| Decision Date | 2019-03-18 |
| PMA | P160021 |
| Supplement | S018 |
| Product Code | PRL |
| 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 |
|---|---|---|
| P160021 | Original Filing | |
| S036 | 2022-12-15 | 30-day Notice |
| S035 | 2022-06-08 | 30-day Notice |
| S034 | 2022-02-11 | 30-day Notice |
| S033 | 2022-01-20 | 30-day Notice |
| S032 | 2021-07-30 | 30-day Notice |
| S031 | 2021-03-01 | 30-day Notice |
| S030 | 2021-02-25 | 30-day Notice |
| S029 | ||
| S028 | ||
| S027 | 2021-01-13 | 30-day Notice |
| S026 | 2020-03-13 | 30-day Notice |
| S025 | 2020-01-03 | 30-day Notice |
| S024 | ||
| S023 | 2019-06-07 | Normal 180 Day Track No User Fee |
| S022 | 2019-04-26 | 30-day Notice |
| S021 | 2019-04-15 | 30-day Notice |
| S020 | ||
| S019 | 2019-03-01 | 30-day Notice |
| S018 | 2019-03-01 | 30-day Notice |
| S017 | 2019-02-04 | 30-day Notice |
| S016 | ||
| S015 | 2018-11-15 | 30-day Notice |
| S014 | 2018-09-18 | 30-day Notice |
| S013 | 2018-08-24 | 30-day Notice |
| S012 | 2018-07-26 | 30-day Notice |
| S011 | 2018-06-29 | 30-day Notice |
| S010 | 2018-06-07 | 30-day Notice |
| S009 | 2018-05-25 | 30-day Notice |
| S008 | 2018-05-03 | 30-day Notice |
| S007 | ||
| S006 | 2018-04-17 | 30-day Notice |
| S005 | 2018-02-01 | 30-day Notice |
| S004 | 2017-07-17 | 30-day Notice |
| S003 | 2017-07-05 | 30-day Notice |
| S002 | 2017-05-26 | 30-day Notice |
| S001 |