- Device
- Surpass Evolve Flow Diverter Systems
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S015
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2023-12-05
- Decision code
- OK30
- Date received
- 2023-11-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the addition of an alternate tier 2 source for raw material polyacrylic acid that is used in the manufacture of the coating of the delivery wire of the Surpass Evolve Flow Diverter System