PMA P170024S011
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S011
- Product code
- OUT
- Decision date
- 2021-11-30
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Change in the coating lubricity testing from using work-in-progress test articles to core wire only test articles.
Current openFDA PMA Record#
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S011
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2021-11-30
- Decision code
- OK30
- Date received
- 2021-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the coating lubricity testing from using work-in-progress test articles to core wire only test articles.