Surpass Evolve Flow Diverter System
FDA premarket approval P170024/S009 · decided 2021-07-12
Approval details
- PMA number
- P170024
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Surpass Evolve Flow Diverter System
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Stryker Neurovascular
- Date received
- 2021-06-30
- Decision date
- 2021-07-12
- Days to decision
- 12 days
- Decision code
- OK30
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Equipment relocation of the primary coil winders, used in the manufacturing and assembly of the Surpass Evolve Flow Diverter System, from their existing location in a Class 8 cleanroom to a Non-Controlled Environment Area (Non-CE) in the warehouse of Strykers manufacturing facility in Cork, Ireland.
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|---|---|---|
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
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| 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 |