# NeuroPace RNS System

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/neuropace-rns-system-p100026>
- Manufacturer: [Neuropace, Inc.](https://devicerts.com/manufacturers/neuropace-inc) (United States, FDA PMA applicant)
- Device class: Class III (US FDA)
- FDA product code: PFN

## Overview

*AI-generated summary, 2026-09-18. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

The NeuroPace RNS System is an implanted brain stimulator for epilepsy, classified as a Class III medical device. It functions as a responsive neurostimulator designed to deliver targeted electrical stimulation to the brain in real-time, aiming to reduce seizure frequency in eligible patients.

This device is implanted surgically and is intended for use as an adjunctive therapy in individuals aged 18 or older with refractory partial-onset seizures. Supplied as a reusable, MRI-unsafe system, it requires specialized training for implantation and management. Authorized under FDA PMA (P100026), it has been approved for specific patient populations with documented seizure frequency criteria.

## Registrations and authorizations

- **PMA** · FDA PMA · United States · P100026 · decision 2013-11-14 · decision APPR · status: Active

## Recalls

No recall on record.

## Identity

- Generic name: Implanted brain stimulator for epilepsy [FDA PMA]

## Identifiers

- PMA number: P100026 [FDA PMA]
- FDA product code: PFN [FDA PMA]

## Classification

- Device class: Class III [FDA PMA]
- Advisory committee: Neurology [FDA PMA]
- FDA decision: APPR [FDA PMA]

## Source and citation

- Cite as: NeuroPace RNS System, Neuropace, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/neuropace-rns-system-p100026 (data as of 2026-11-14).
- Data sources: [FDA PMA](https://open.fda.gov/apis/device/pma/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-14
- JSON: <https://devicerts.com/devices/neuropace-rns-system-p100026.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/neuropace-rns-system-p100026
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.