This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the surpass streamline flow diverter. The surpass streamline flow diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width >= 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter >= 2. 5 mm and
| Device | Surpass Streamline Flow Diverter |
| Classification Name | Intracranial Aneurysm Flow Diverter |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Stryker Neurovascular |
| Date Received | 2017-07-31 |
| Decision Date | 2018-07-13 |
| Notice Date | 2018-07-26 |
| PMA | P170024 |
| Supplement | S |
| Product Code | OUT |
| Docket Number | 18M-2884 |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |