|
Device | Surpass Streamline Flow Diverter |
Generic Name | Intracranial aneurysm flow diverter |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
PMA Number | P170024 |
Supplement Number | S006 |
Date Received | 11/24/2020 |
Decision Date | 12/15/2020 |
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 optimization changes to the ethylene oxide (EO) sterilization cycle used for sterilization of the Surpass Streamline Flow Diverter |