PMA P170024S024

Device: Surpass Streamline Flow Diverter
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S024
Product code: OUT
Decision date: 2025-08-20
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval for manufacturing process improvements for the manufacturing line for the Surpass Evolve Flow Diverter System (FDS) and Surpass Elite Flow Diverter System, as well as Stent Loader equipment upgrades for Surpass Evolve FDS.

Current openFDA PMA Record#

Device: Surpass Streamline Flow Diverter
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S024
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2025-08-20
Decision code: OK30
Date received: 2025-07-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for manufacturing process improvements for the manufacturing line for the Surpass Evolve Flow Diverter System (FDS) and Surpass Elite Flow Diverter System, as well as Stent Loader equipment upgrades for Surpass Evolve FDS.