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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceNeuroPace® RNS® System
Generic NameImplanted brain stimulator for epilepsy
ApplicantNEUROPACE INC
455 N. BERNARDO AVE
MOUNTAIN VIEW, CA 94043
PMA NumberP100026
Supplement NumberS092
Date Received10/17/2022
Decision Date02/10/2023
Product Code PFN 
Advisory Committee Neurology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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