Surpass Streamline Flow Diverter
FDA premarket approval P170024/S004 · decided 2020-09-14
Approval details
- PMA number
- P170024
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Surpass Streamline Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Stryker Neurovascular
- Date received
- 2020-06-02
- Decision date
- 2020-09-14
- Days to decision
- 104 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for a shelf-life extension of the Surpass Streamline Flow Diverter from one year to three years.
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