PMA P100026

Device
NeuroPace® RNS® System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S091
Product code
PFN
Decision date
2026-06-17
Generic name
Implanted brain stimulator for epilepsy
Approval order statement
approval for migration of the Patient Data Management System from on-site server to cloud service

Current openFDA PMA Record#

Device
NeuroPace® RNS® System
Applicant
NeuroPace, Inc.
PMA number
P100026
Supplement
S100
Product code
PFN
Generic name
Implanted brain stimulator for epilepsy
Decision date
2026-06-17
Decision code
APPR
Date received
2025-07-24
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
approval for migration of the Patient Data Management System from on-site server to cloud service