FDA.reportPublic FDA data

PMA P100026S092

Device
NeuroPace® RNS® System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S092
Product code
PFN
Decision date
2023-02-10
Classification
Neurology
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
Approval for a revised the RNS System Implanting and Programming Program Qualifications Questionnaire as follows:1) Provided a list of current diagnostic technologies utilized to identify the seizure onset;2) Clarified that qualified neurosurgeon(s) are ABNS board-certified or board-eligible and tracking toward certification, with experience in epilepsy surgery procedures and placement of intracranial electrodes;3) Specified that an established referral relationship is needed to ensure access to neuropsychological testing and mental health services; and4) Neurologist(s) who is American Board of Psychiatry and Neurology (ABPN) board- certified and is fellowship trained in epilepsy or in clinical neurophysiology, or has experience in the treatment of epilepsy, including selection of antiepileptic medications, interpretation of scalp and intracranial EEG, video EEG monitoring, and selection of patients for epilepsy surgery or neuromodulation devices.2. Revised the RNS System Programming Physician Qualifications Questionnaire as follows:1) At least one American Board of Psychiatry and Neurology (ABPN) board-certified neurologist with expertise in epilepsy and in the interpretation of EEG;2) Established referral relationship with Epilepsy Program qualified to implant and program the RNS System;3) Local access to urgent or emergent neurosurgical care; and4) Capability to provide instructions to patient and family members in RNS System use.

Current openFDA PMA Record#

Device
NeuroPace® RNS® System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S092
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2023-02-10
Decision code
APPR
Date received
2022-10-17
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a revised the RNS System Implanting and Programming Program Qualifications Questionnaire as follows:1) Provided a list of current diagnostic technologies utilized to identify the seizure onset;2) Clarified that qualified neurosurgeon(s) are ABNS board-certified or board-eligible and tracking toward certification, with experience in epilepsy surgery procedures and placement of intracranial electrodes;3) Specified that an established referral relationship is needed to ensure access to neuropsychological testing and mental health services; and4) Neurologist(s) who is American Board of Psychiatry and Neurology (ABPN) board- certified and is fellowship trained in epilepsy or in clinical neurophysiology, or has experience in the treatment of epilepsy, including selection of antiepileptic medications, interpretation of scalp and intracranial EEG, video EEG monitoring, and selection of patients for epilepsy surgery or neuromodulation devices.2. Revised the RNS System Programming Physician Qualifications Questionnaire as follows:1) At least one American Board of Psychiatry and Neurology (ABPN) board-certified neurologist with expertise in epilepsy and in the interpretation of EEG;2) Established referral relationship with Epilepsy Program qualified to implant and program the RNS System;3) Local access to urgent or emergent neurosurgical care; and4) Capability to provide instructions to patient and family members in RNS System use.