PMA P170024S004
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S004
- Product code
- OUT
- Decision date
- 2020-09-14
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for a shelf-life extension of the Surpass Streamline Flow Diverter from one year to three years.
Current openFDA PMA Record#
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S004
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2020-09-14
- Decision code
- APPR
- Date received
- 2020-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a shelf-life extension of the Surpass Streamline Flow Diverter from one year to three years.