PMA P100026
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S091
- Product code
- PFN
- Decision date
- 2026-08-19
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- to remove an in-process screening test used in the manufacture of the RNS-320 Neurostimulators
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S104
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2026-08-19
- Decision code
- OK30
- Date received
- 2026-07-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove an in-process screening test used in the manufacture of the RNS-320 Neurostimulators