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.
Transferring manufacturing of raw materials, intermediate materials and manufacturing aids to an external supplier.
| Device | GORE VIABAHN VBX Balloon Expandable Endoprosthesis |
| Classification Name | Iliac Covered Stent, Arterial |
| Generic Name | Iliac Covered Stent, Arterial |
| Applicant | W. L. Gore & Associates, Inc. |
| Date Received | 2018-06-29 |
| Decision Date | 2018-07-27 |
| PMA | P160021 |
| Supplement | S011 |
| 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 |