Surpass Streamline Flow Diverter
PMA P170024
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPPR | NumberP170024 | Date13 Jul 2018 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Surpass Evolve Flow Diverter Systems
- Trade Name
- Surpass Streamline Flow Diverter
- Generic Name
- Intracranial aneurysm flow diverter
- PMA Number
- FDA Product Code
- OUT
- Device Class
- Class III
- Advisory Committee
- Neurology
- FDA Decision
- APPR Approved
Overview
AI-generated summary, 18 Sep 2026
The Surpass Streamline Flow Diverter is an intracranial aneurysm flow diverter, classified as a Class III medical device. It is designed to promote thrombosis within an aneurysm sac by diverting blood flow through its porous structure, thereby reducing pressure and promoting natural healing of unruptured large or giant saccular aneurysms with specific morphological criteria, including wide-neck configurations and fusiform aneurysms in the internal carotid artery.
This device is supplied as a single-use, endovascular implant and is intended for use in neurovascular procedures. It requires sterile handling and is intended for deployment via microcatheter systems in controlled clinical settings. The device is MRI-safe under specified conditions and is available in various sizes to accommodate parent vessel diameters ranging from 2.5 mm to 5.3 mm. Authorized for use in the United States under an FDA Premarket Approval (PMA), the Surpass Streamline Flow Diverter is regulated under the device classification for intracranial aneurysm flow diverters.