Neuroform Atlas® Stent System
FDA premarket approval P180031 · decided 2019-05-16
Approval details
- PMA number
- P180031
- Trade name
- Neuroform Atlas® Stent System
- Generic name
- Intracranial coil-assist stent
- Applicant
- Stryker Neurovascular
- Date received
- 2018-08-15
- Decision date
- 2019-05-16
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- QCA
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
| AXS Lift Intracranial Base Catheter (K253032) | Stryker Neurovascular | 2026-02-11 |
| Target Detachable Coil (K252694) | Stryker Neurovascular | 2025-12-11 |
| InZone IST Detachment System; IZDS Connecting Cable (K251832) | Stryker Neurovascular | 2025-10-17 |
| Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter (K242289) | Stryker Neurovascular | 2025-03-21 |
| AXS Lift Intracranial Base Catheter (K243593) | Stryker Neurovascular | 2025-02-18 |
| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |