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NeuroPace RNS System

by Neuropace, Inc.

PMA P100026

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P100026↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP100026 Date14 Nov 2013ApprovedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Implanted brain stimulator for epilepsy
PMA number
FDA product code
PFN
Device class
Class III
Advisory committee
Neurology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above 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.

Devices cleared under P100026

35 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under P100026
UDI-DISize and differences
Connector Cover Kit CC-01-K
Neuropace, Inc.
CC-01-K00855547005397
Prescription: yes; Single use: yes
On the market
Connector Cover Kit CC-01-K
Neuropace, Inc.
CC-01-K00855547005151
Prescription: yes; Single use: yes
On the market
Craniectomy Template Kit CT-01-K
Neuropace, Inc.
CT-01-K00855547005168
Prescription: yes; Single use: yes
On the market
Craniectomy Template Kit CT-01-K
Neuropace, Inc.
CT-01-K00855547005380
Prescription: yes; Single use: yes
On the market
Explant Kit EX-01-K
Neuropace, Inc.
EX-01-K00855547005410
Prescription: yes; Single use: yes
On the market
Ferrule Kit F-01-K
Neuropace, Inc.
F-01-K00855547005373
Prescription: yes; Single use: yes
On the market
Ferrule Kit F-01-K
Neuropace, Inc.
F-01-K00855547005175
Prescription: yes; Single use: yes
On the market
Magnet M-01
Neuropace, Inc.
M-0100855547005137
Prescription: yes; Single use: no
On the market
NeuroPace® Cortical Strip Lead Kit CL-315-10-K
Neuropace, Inc.
CL-315-10-K00855547005328
Length 15 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Cortical Strip Lead Kit CL-315-10-K
Neuropace, Inc.
CL-315-10-K00855547005076
Length 15 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Cortical Strip Lead Kit CL-325-10-K
Neuropace, Inc.
CL-325-10-K00855547005311
Length 25 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Cortical Strip Lead Kit CL-325-10-K
Neuropace, Inc.
CL-325-10-K00855547005069
Length 25 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Cortical Strip Lead Kit CL-335-10-K
Neuropace, Inc.
CL-335-10-K00855547005052
Length 35 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Cortical Strip Lead Kit CL-335-10-K
Neuropace, Inc.
CL-335-10-K00855547005304
Length 35 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-330-10-K
Neuropace, Inc.
DL-330-10-K00855547005335
Length 30 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-330-10-K
Neuropace, Inc.
DL-330-10-K00855547005045
Length 30 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-330-3.5-K
Neuropace, Inc.
DL-330-3.5-K00855547005342
Length 30 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-330-3.5-K
Neuropace, Inc.
DL-330-3.5-K00855547005038
Length 30 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-344-10-K
Neuropace, Inc.
DL-344-10-K00855547005298
Length 44 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-344-10-K
Neuropace, Inc.
DL-344-10-K00855547005014
Length 44 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-344-3.5-K
Neuropace, Inc.
DL-344-3.5-K00855547005359
Length 44 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Depth Lead Kit DL-344-3.5-K
Neuropace, Inc.
DL-344-3.5-K00855547005021
Length 44 cm
Prescription: yes; Single use: yes
On the market
NeuroPace® Lead Accessory Kit LA-02-K
Neuropace, Inc.
LA-02-K00855547005229
Prescription: yes; Single use: yes
On the market
NeuroPace® Patient Data Management System (PDMS) Model 4340
Neuropace, Inc.
Model 434000855547005007
Prescription: yes; Single use: no
On the market
NeuroPace® Programmer Kit PGM-300-K
Neuropace, Inc.
PGM-300-K00855547005106
Prescription: yes; Single use: no
On the market
NeuroPace® Remote Monitor Kit 5101
Neuropace, Inc.
510100855547005250
Prescription: yes; Single use: no
On the market
NeuroPace® Remote Monitor Kit 5107
Neuropace, Inc.
510700855547005427
Prescription: yes; Single use: no
On the market
NeuroPace® Remote Monitor Kit DTR-300-E-K
Neuropace, Inc.
DTR-300-E-K00855547005090
Prescription: yes; Single use: no
On the market
NeuroPace® Remote Monitor Kit DTR-300-K
Neuropace, Inc.
DTR-300-K00855547005083
Prescription: yes; Single use: no
On the market
Remote Monitor Phone Accessories 5104
Neuropace, Inc.
510400855547005403
Prescription: yes; Single use: no
On the market
RNS® Neurostimulator Kit RNS-300M-K
Neuropace, Inc.
RNS-300M-K00855547005120
Prescription: yes; Single use: yes
On the market
RNS® Neurostimulator Kit RNS-320-K
Neuropace, Inc.
RNS-320-K00855547005267
Prescription: yes; Single use: yes
On the market
RNS® Neurostimulator Kit RNS-320-K
Neuropace, Inc.
RNS-320-K00855547005366
Prescription: yes; Single use: yes
On the market
RNS® Tablet Kit 5001
Neuropace, Inc.
500100855547005281
Prescription: no; Single use: no
On the market
Wand W-02
Neuropace, Inc.
W-0200855547005113
Prescription: yes; Single use: no
On the market

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