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.
Implement upgraded equipment and software used for heparin analytical testing.
| Device | GORE Carotid Stent |
| Classification Name | Stent, Carotid |
| Generic Name | Stent, Carotid |
| Applicant | W. L Gore & Associates, Inc |
| Date Received | 2018-11-15 |
| Decision Date | 2018-12-13 |
| PMA | P180010 |
| Supplement | S001 |
| 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 |