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.
Change in the coating lubricity testing from using work-in-progress test articles to core wire only test articles
| Device | Surpass Evolve Flow Diverter System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Stryker Neurovascular |
| Date Received | 2021-11-09 |
| Decision Date | 2021-11-30 |
| PMA | P170024 |
| Supplement | S011 |
| Product Code | OUT |
| Advisory Committee | Neurology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170024 | Original Filing | |
| S011 | 2021-11-09 | 30-day Notice |
| S010 | ||
| S009 | 2021-06-30 | 30-day Notice |
| S008 | 2021-06-07 | 30-day Notice |
| S007 | 2021-04-14 | 30-day Notice |
| S006 | 2020-11-24 | 30-day Notice |
| S005 | 2020-10-26 | 30-day Notice |
| S004 | 2020-06-02 | Real-time Process |
| S003 | 2019-03-04 | Normal 180 Day Track |
| S002 | 2018-10-15 | Special (immediate Track) |
| S001 | 2018-09-20 | 30-day Notice |