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.
Equipment relocation of the primary coil winders, used in the manufacturing and assembly of the surpass evolve flow diverter system, from their existing location in a class 8 cleanroom to a non-controlled environment area (non-ce) in the warehouse of stryker’s manufacturing facility in cork, ireland
| Device | Surpass Evolve Flow Diverter System |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Stryker Neurovascular |
| Date Received | 2021-06-30 |
| Decision Date | 2021-07-12 |
| PMA | P170024 |
| Supplement | S009 |
| 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 |