The neuroform atlas stent system is indicated for use with neurovascular embolization coils in the anterior circulation of the neurovasculature for the endovascular treatment of patients? 18 years of age with saccular wide-necked (neck width? 4 mm or a dome-to-neck ratio of < 2) intracranial aneurysms arising from a parent vessel with a diameter of? 2. 0 mm and? 4. 5 mm.
| Device | Neuroform Atlas® Stent System |
| Generic Name | Intracranial Coil-assist Stent |
| Applicant | Stryker Neurovascular |
| Date Received | 2019-08-21 |
| Decision Date | 2020-01-18 |
| PMA | P180031 |
| Supplement | S002 |
| Product Code | QCA |
| Advisory Committee | Neurology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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