|
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 | S088 |
Date Received | 10/28/2021 |
Decision Date | 01/18/2022 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to modify the labeling for the NeuroPace® RNS® Neurostimulator model RNS-320 to provide updated estimates for battery longevity. |