- Device
- Neuroform Atlas® Stent System
- Applicant
- Stryker Neurovascular
- PMA number
- P180031
- Supplement
- S001
- Product code
- QCA
- Generic name
- Intracranial coil-assist stent
- Decision date
- 2020-07-30
- Decision code
- APPR
- Date received
- 2019-07-22
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the Neuroform Atlas Stent System indicated for use with neurovascular embolization coils in the anterior and posterior 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