PMA P170024S005
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S005
- Product code
- OUT
- Decision date
- 2020-11-17
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Automate the application of the hydrophilic coating on the Surpass Evolve Flow Diverter System.
Current openFDA PMA Record#
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S005
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-11-17
- Decision code
- OK30
- Date received
- 2020-10-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate the application of the hydrophilic coating on the Surpass Evolve Flow Diverter System.