PMA P170024S026

Device: Surpass Evolve; Surpass Elite FDS
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S026
Product code: OUT
Decision date: 2026-06-26
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: approval for addition of a new supplier for the polytetrafluoroethylene (PTFE) material used in the Introducer Sheath Assembly for the Surpass Flow Diverter System (Evolve and Elite)

Current openFDA PMA Record#

Device: Surpass Evolve; Surpass Elite FDS
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S026
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2026-06-26
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for addition of a new supplier for the polytetrafluoroethylene (PTFE) material used in the Introducer Sheath Assembly for the Surpass Flow Diverter System (Evolve and Elite)