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 revisions to the directions for use (dfu) to include additional precautionary language regarding the use of magnetic resonance angiography (mra) for patient follow-up to assess intracranial aneurysm occlusion.
| Device | Surpass Streamline Flow Diverter |
| Classification Name | Intracranial Aneurysm Flow Diverter |
| Generic Name | Intracranial Aneurysm Flow Diverter |
| Applicant | Stryker Neurovascular |
| Date Received | 2018-10-15 |
| Decision Date | 2018-11-14 |
| PMA | P170024 |
| Supplement | S002 |
| Product Code | OUT |
| Advisory Committee | Neurology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |