- Device
- Surpass Streamline Flow Diverter System, Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S008
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-06-09
- Decision code
- OK30
- Date received
- 2021-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier to update to a newer model of a heat treatment furnace for the manufacturing of the Surpass Streamline Flow Diverter System and the Surpass Evolve Flow Diverter System.