Approved for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients greater or equal to 18 years of age with saccular wide-necked (neck width greater or equal to 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of greater or equal to 2. 0 mm and less than or equal to 4. 5 mm.
| Device | Neuroform Atlas® Stent System |
| Classification Name | Intracranial Coil-assist Stent |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | Stryker Neurovascular |
| Date Received | 2018-08-15 |
| Decision Date | 2019-05-16 |
| PMA | P180031 |
| Supplement | S |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Stryker Neurovascular 47900 Bayside Parkway fremont, CA 94538 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180031 | | Original Filing |
| S005 |
2022-09-20 |
30-day Notice |
| S004 |
2022-01-12 |
30-day Notice |
| S003 |
2020-08-04 |
30-day Notice |
| S002 |
2019-08-21 |
Normal 180 Day Track No User Fee |
| S001 | | |
NIH GUDID Devices