Neuroform Atlas® Stent System
FDA premarket approval P180031/S001 · decided 2020-07-30
Approval details
- PMA number
- P180031
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Neuroform Atlas® Stent System
- Generic name
- Intracranial coil-assist stent
- Applicant
- Stryker Neurovascular
- Date received
- 2019-07-22
- Decision date
- 2020-07-30
- Days to decision
- 374 days
- Decision code
- APPR
- Product code
- QCA
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- 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 <= 4.5 mm.
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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 |