PMA P170024S020

Device: Surpass Evolve and Elite Flow Diverter
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S020
Product code: OUT
Decision date: 2024-09-05
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: the addition of an alternate source of raw material (Pharma Grade Sodium Hyaluronate Acid) which is used in the manufacture of the Hydak T-070 top coat solution for the delivery wire

Current openFDA PMA Record#

Device: Surpass Evolve and Elite Flow Diverter
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S020
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-09-05
Decision code: OK30
Date received: 2024-08-07
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the addition of an alternate source of raw material (Pharma Grade Sodium Hyaluronate Acid) which is used in the manufacture of the Hydak T-070 top coat solution for the delivery wire