|
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 | S075 |
Date Received | 09/30/2019 |
Decision Date | 12/17/2019 |
Product Code |
PFN |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for 1) a firmware update (RAM 7.101) to the RNS Neurostimulator (model RNS-320) to disable Long Episode counting during telemetry; and 2) an adjustment to the crystal oscillator trim value (from 00h to 64h) on the neurostimulator to mitigate the possibility of the device unnecessarily transitioning into passive mode. |