|
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 | S009 |
Date Received | 06/30/2021 |
Decision Date | 07/12/2021 |
Product Code |
OUT |
Advisory Committee |
Neurology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Equipment relocation of the primary coil winders, used in the manufacturing and assembly of the Surpass Evolve Flow Diverter System, from their existing location in a Class 8 cleanroom to a Non-Controlled Environment Area (Non-CE) in the warehouse of Stryker’s manufacturing facility in Cork, Ireland. |