- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S023
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2025-05-30
- Decision code
- OK30
- Date received
- 2025-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate source of the hardener component of the Epoxy adhesive used in the manufacture of the Surpass Evolve Flow Diverter System and Surpass Elite Flow Diverter System