PMA P170024S014

Device: Surpass Evolve Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S014
Product code: OUT
Decision date: 2024-03-12
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: Approval for a supplier-initiated change request for the cyanoacrylate adhesive used to bond the distal protection assembly onto the distal coil of the delivery wire of the Surpass Evolve Flow Diverter System.

Current openFDA PMA Record#

Device: Surpass Evolve Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S014
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-03-12
Decision code: APPR
Date received: 2023-11-06
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a supplier-initiated change request for the cyanoacrylate adhesive used to bond the distal protection assembly onto the distal coil of the delivery wire of the Surpass Evolve Flow Diverter System.