PMA P170024S006
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S006
- Product code
- OUT
- Decision date
- 2020-12-15
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- optimization changes to the ethylene oxide (EO) sterilization cycle used for sterilization of the Surpass Streamline Flow Diverter
Current openFDA PMA Record#
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S006
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-12-15
- Decision code
- OK30
- Date received
- 2020-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- optimization changes to the ethylene oxide (EO) sterilization cycle used for sterilization of the Surpass Streamline Flow Diverter