PMA P100026S075

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
Product code: PFN
Decision date: 2019-12-17
Generic name: Implanted brain stimulator for epilepsy
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.

Current openFDA PMA Record#

Device: NeuroPace RNS System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S075
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2019-12-17
Decision code: APPR
Date received: 2019-09-30
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.