|
Device | NeuroPace® RNS® System |
Generic Name | Implanted brain stimulator for epilepsy |
Applicant | NEUROPACE INC 455 N. BERNARDO AVE MOUNTAIN VIEW, CA 94043 |
PMA Number | P100026 |
Supplement Number | S091 |
Date Received | 09/26/2022 |
Decision Date | 12/29/2022 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to use a second contract sterilizer for the ethylene oxide (EO) sterilization of RNS System products. |