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 implement the use of new cleanrooms
| Device | GORE Carotid Stent |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | W. L Gore & Associates, Inc |
| Date Received | 2019-03-01 |
| Decision Date | 2019-03-18 |
| PMA | P180010 |
| Supplement | S004 |
| Product Code | NIM |
| 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 4250 W. Kiltie Lane flagship, AZ 86005 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180010 | Original Filing | |
| S004 | 2019-03-01 | 30-day Notice |
| S003 | 2019-02-04 | 30-day Notice |
| S002 | ||
| S001 | 2018-11-15 | 30-day Notice |