Surpass Streamline Flow Diverter
FDA premarket approval P170024/S002 · decided 2018-11-14
Approval details
- PMA number
- P170024
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- 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
- 2018-10-15
- Decision date
- 2018-11-14
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for revisions to the Directions for Use (DFU) to include additional precautionary language regarding the use of magnetic resonance angiography (MRA) for patient follow-up to assess intracranial aneurysm occlusion.
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|---|---|---|
| Trevo Trak 21 Microcatheter (K261889) | Stryker Neurovascular | 2026-07-01 |
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| AXS Lift Intracranial Base Catheter (K243593) | Stryker Neurovascular | 2025-02-18 |
| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |