{
  "format": "devicerts.device.v1",
  "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).",
  "source": {
    "canonical_url": "https://devicerts.com/devices/neuropace-rns-system-p100026",
    "json_url": "https://devicerts.com/devices/neuropace-rns-system-p100026.json",
    "markdown_url": "https://devicerts.com/devices/neuropace-rns-system-p100026.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "FDA PMA",
        "url": "https://open.fda.gov/apis/device/pma/"
      }
    ],
    "registry_records_last_synced": "2026-10-06",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "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",
    "disclaimer": "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."
  },
  "device": {
    "name": "NeuroPace RNS System",
    "registry_name": "NeuroPace RNS System",
    "url": "https://devicerts.com/devices/neuropace-rns-system-p100026",
    "manufacturer": {
      "name": "Neuropace, Inc.",
      "url": "https://devicerts.com/manufacturers/neuropace-inc",
      "country": "United States",
      "country_basis": "FDA PMA applicant",
      "fda_registration_country": null
    },
    "status": {
      "state": "active",
      "label": "Active",
      "detail": "United States"
    },
    "classification": [
      {
        "class": "Class III",
        "system": "US FDA"
      }
    ],
    "identifiers": [
      {
        "label": "PMA number",
        "values": [
          {
            "value": "P100026",
            "registries": [
              "FDA PMA"
            ]
          }
        ]
      }
    ],
    "product_codes": [
      "PFN"
    ],
    "emdn": [],
    "gmdn": [],
    "description": {
      "text": "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.\n\nThis 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.",
      "ai_generated": true,
      "generated_on": "2026-09-18",
      "note": "Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record."
    },
    "noindex": false
  },
  "authorizations": [
    {
      "registry": "PMA",
      "region": "United States",
      "type": "FDA PMA",
      "number": "P100026",
      "number_label": null,
      "device_udi_di": null,
      "date": "2013-11-14",
      "date_kind": "decision",
      "decision_code": "APPR",
      "expires": null,
      "withdrawn": null,
      "status": "Active",
      "status_note": null,
      "derived_from_gudid": false
    }
  ],
  "no_longer_listed_by": [],
  "certificates": [],
  "recalls": [],
  "eu_market_availability": null,
  "properties": [
    {
      "group": "Identity",
      "fields": [
        {
          "label": "Generic name",
          "values": [
            {
              "value": "Implanted brain stimulator for epilepsy",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Identifiers",
      "fields": [
        {
          "label": "PMA number",
          "values": [
            {
              "value": "P100026",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        },
        {
          "label": "FDA product code",
          "values": [
            {
              "value": "PFN",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        }
      ]
    },
    {
      "group": "Classification",
      "fields": [
        {
          "label": "Device class",
          "values": [
            {
              "value": "Class III",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        },
        {
          "label": "Advisory committee",
          "values": [
            {
              "value": "Neurology",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        },
        {
          "label": "FDA decision",
          "values": [
            {
              "value": "APPR",
              "registries": [
                "FDA PMA"
              ]
            }
          ]
        }
      ]
    }
  ]
}