|
Device | Neuroform Atlas® Stent System |
Generic Name | Intracranial coil-assist stent |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
PMA Number | P180031 |
Date Received | 08/15/2018 |
Decision Date | 05/16/2019 |
Product Code |
QCA |
Docket Number | 19M-2408 |
Notice Date | 05/20/2019 |
Advisory Committee |
Neurology |
Clinical Trials | NCT02340585
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S002 S001 S003 S005 S004 |