Neuroform Atlas® Stent System
FDA premarket approval P180031/S006 · decided 2025-06-24
Approval details
- PMA number
- P180031
- Supplement
- S006
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Neuroform Atlas® Stent System
- Generic name
- Intracranial coil-assist stent
- Applicant
- Stryker Neurovascular
- Date received
- 2024-08-12
- Decision date
- 2025-06-24
- Days to decision
- 316 days
- Decision code
- APPR
- Product code
- QCA
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- PMA was approved on May 16, 2019 with the following conditions of approval:PMA Post-Approval Study: Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System (ATLAS): The Office of Neurological and Physical Medicine Devices (Office of Health Technology (OHT) 5) will have the lead for this study initiated prior to device approval. The ATLAS study was conducted under investigational device exemption (IDE) G150006 and patients w
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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 |