PMA P170024S022
- Device
- Surpass Elite Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S022
- Product code
- OUT
- Decision date
- 2025-02-12
- Classification
- Neurology
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for a line extension for the Surpass Elite Flow Diverter System, which adds intermediate stent diameters of 3.75mm, 4.25mm, and 4.75mm.
Current openFDA PMA Record#
- Device
- Surpass Elite Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S022
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2025-02-12
- Decision code
- APPR
- Date received
- 2024-11-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a line extension for the Surpass Elite Flow Diverter System, which adds intermediate stent diameters of 3.75mm, 4.25mm, and 4.75mm.