PMA P170024S016
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S016
- Product code
- OUT
- Decision date
- 2024-05-30
- Classification
- Neurology
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- the addition of an alternate supplier for the raw material used in the coating of the delivery wire of the Surpass Evolve Flow Diverter System
Current openFDA PMA Record#
- Device
- Surpass Evolve Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S016
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-05-30
- Decision code
- OK30
- Date received
- 2024-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternate supplier for the raw material used in the coating of the delivery wire of the Surpass Evolve Flow Diverter System