PMA P100026S101

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S101
Product code: PFN
Decision date: 2026-05-28
Classification: Neurology
Generic name: Implanted brain stimulator for epilepsy
Approval order statement: approval for an optional Electrocorticogram (ECoG) Assistant function, which is a clinician tool that highlights ECoG recordings of interest, for the Patient Data Management System.

Current openFDA PMA Record#

Device: NeuroPace® RNS® System
Applicant: NeuroPace, Inc.
PMA number: P100026
Supplement: S101
Product code: PFN
Generic name: Implanted brain stimulator for epilepsy
Decision date: 2026-05-28
Decision code: APPR
Date received: 2025-08-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for an optional Electrocorticogram (ECoG) Assistant function, which is a clinician tool that highlights ECoG recordings of interest, for the Patient Data Management System.