PMA P170024S012

Device: Surpass Elite Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S012
Product code: OUT
Decision date: 2024-05-18
Classification: Neurology
Generic name: Intracranial aneurysm flow diverter
Approval order statement: the Surpass Elite Flow Diverter System that was developed through design modifications to the approved Surpass Evolve Flow Diverter System (P170024/S003). The design modifications consist of changes to the delivery system resheath pad and distal protection assembly, the stent braid to include a 5.25 mm diameter stent model and picks per inch specifications to be the same for all stent diameters, and manufacturing process for the stent braid and delivery system.

Current openFDA PMA Record#

Device: Surpass Elite Flow Diverter System
Applicant: Stryker Neurovascular
PMA number: P170024
Supplement: S012
Product code: OUT
Generic name: Intracranial aneurysm flow diverter
Decision date: 2024-05-18
Decision code: APPR
Date received: 2023-05-01
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: the Surpass Elite Flow Diverter System that was developed through design modifications to the approved Surpass Evolve Flow Diverter System (P170024/S003). The design modifications consist of changes to the delivery system resheath pad and distal protection assembly, the stent braid to include a 5.25 mm diameter stent model and picks per inch specifications to be the same for all stent diameters, and manufacturing process for the stent braid and delivery system.