PMA P170024S009

Device: Surpass Evolve Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S009
Product code: OUT
Decision date: 2021-07-12
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Equipment relocation of the primary coil winders, used in the manufacturing and assembly of the Surpass Evolve Flow Diverter System, from their existing location in a Class 8 cleanroom to a Non-Controlled Environment Area (Non-CE) in the warehouse of Stryker’s manufacturing facility in Cork, Ireland.

Current openFDA PMA Record#

Device: Surpass Evolve Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S009
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2021-07-12
Decision code: OK30
Date received: 2021-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Equipment relocation of the primary coil winders, used in the manufacturing and assembly of the Surpass Evolve Flow Diverter System, from their existing location in a Class 8 cleanroom to a Non-Controlled Environment Area (Non-CE) in the warehouse of Stryker’s manufacturing facility in Cork, Ireland.