Surpass Streamline Flow Diverter
FDA premarket approval P170024 · decided 2018-07-13
Approval details
- PMA number
- P170024
- Trade name
- Surpass Streamline Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Applicant
- Stryker Neurovascular
- Date received
- 2017-07-31
- Decision date
- 2018-07-13
- Days to decision
- 347 days
- Decision code
- APPR
- Product code
- OUT
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Fremont, CA
- Statement
- Approval for The Surpass Streamline Flow Diverter. The Surpass Streamline Flow Diverter is indicated for use in the endovascular treatment of patients (18 years of age and older) with unruptured large or giant saccular wide-neck (neck width >= 4 mm or dome-to-neck ratio < 2) or fusiform intracranial aneurysms in the internal carotid artery from the petrous segment to the terminus arising from a parent vessel with a diameter >= 2.5 mm and <= 5.3 mm.
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|---|---|---|
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| Broadway 8 Catheter (K241768) | Stryker Neurovascular | 2024-12-19 |
| Echo Intracranial Base Catheter (K241637) | Stryker Neurovascular | 2024-12-19 |