- Device
- Surpass Evolve Flow Diverter Systems, Surpass Elite Flow Diverter Systems
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S021
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-10-06
- Decision code
- OK30
- Date received
- 2024-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a modification to the viscosity test method and acceptance criteria for delivery wire coating solutions for the Surpass Evolve and Surpass Elite Flow Diverter Systems