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.
Approval for a supplier to update to a newer model of a heat treatment furnace for the manufacturing of the surpass streamline flow diverter system and the surpass evolve flow diverter system
| Device | Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Stryker Neurovascular |
| Date Received | 2021-06-07 |
| Decision Date | 2021-06-09 |
| PMA | P170024 |
| Supplement | S008 |
| 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 |