Atlas FDA

Surpass Elite Flow Diverter System

FDA premarket approval P170024/S012 · decided 2024-05-18

Approval details

PMA number
P170024
Supplement
S012
Supplement type
Normal 180 Day Track
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Trade name
Surpass Elite Flow Diverter System
Generic name
Intracranial aneurysm flow diverter
Applicant
Stryker Neurovascular
Date received
2023-05-01
Decision date
2024-05-18
Days to decision
383 days
Decision code
APPR
Product code
OUT
Advisory committee
Neurology
Expedited review
No
Location
Fremont, CA
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.

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