|
Device | Surpass Evolve Flow Diverter System |
Generic Name | Intracranial aneurysm flow diverter |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
PMA Number | P170024 |
Supplement Number | S003 |
Date Received | 03/04/2019 |
Decision Date | 05/20/2020 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change in the design of the approved Surpass Streamline Flow Diverter that consists of a new delivery system, smaller gauge wire in the stent to enable delivery through a smaller microcatheter, and reduce the number of cobalt chromium wires used in the stent braid. |