Identity
- Trade Name
- NEUROPACE RNS SYSTEM FDA PMA
- 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 Approved FDA PMA
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.
Frequently asked questions
What specific patient criteria must be met for the NeuroPace RNS System to be considered as an adjunctive therapy for epilepsy?
The NeuroPace RNS System is approved for use as an adjunctive therapy in patients aged 18 or older who have **refractory partial-onset seizures** with diagnostic testing confirming **no more than two epileptogenic foci**. Patients must also have **failed two or more antiepileptic medications** and currently experience **frequent, disabling seizures**, averaging **three or more per month** over the prior three months (with no month having fewer than two seizures). The system has not been evaluated for patients with less frequent seizures.
Is the NeuroPace RNS System reusable, and what considerations should be made for its use?
Yes, the NeuroPace RNS System is designed as a **reusable** device. However, it is **MRI-unsafe**, meaning patients cannot undergo MRI scans while the system is implanted. Specialized training is required for both **implantation and ongoing management**, as it involves real-time brain stimulation to help reduce seizure frequency.
How was the regulatory approval for the NeuroPace RNS System determined, and what does the PMA number indicate?
The NeuroPace RNS System received **FDA approval via a Premarket Approval (PMA)** under the PMA number **P100026**, which is a rigorous review process for Class III devices. This approval confirms the device’s **safety and effectiveness** for its specified indication, as outlined in the advisory committee’s authorization statement, which details the exact patient criteria and seizure frequency requirements.
What type of seizures does the NeuroPace RNS System target, and what are the key seizure characteristics required for eligibility?
The system targets **partial-onset seizures**, including **motor partial seizures, complex partial seizures, and/or secondarily generalized seizures**. Eligible patients must have **documented refractory seizures** despite treatment with **two or more antiepileptic drugs** and exhibit **frequent, disabling episodes**—specifically averaging **three or more seizures per month** over the prior three months, with no month having fewer than two seizures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P100026 | Class III | Active |
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Manufacturer
- Manufacturer
- Neuropace, Inc.
Sources (1)
- FDA PMA P100026 24 fields · synced Sep 18, 2026