- Device
- Surpass Evolve Flow Diverter Systems
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S019
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-08-05
- Decision code
- OK30
- Date received
- 2024-07-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the modification of the Upper Tensile Strength (UTS) specification of the platinum/tungsten wire, a component used in the Surpass Evolve Flow Diverter System