|
Device | Neuroform Atlas® Stent System |
Generic Name | Intracranial coil-assist stent |
Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 |
PMA Number | P180031 |
Supplement Number | S005 |
Date Received | 09/20/2022 |
Decision Date | 11/15/2022 |
Product Code |
QCA |
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 Change to the in-process specification of the inner diameter of the nitinol stent component of the Neuroform Atlas Stent System, |