PMA P100026S099
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S099
- Product code
- PFN
- Decision date
- 2025-08-18
- Classification
- Neurology
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- approval for the approved supplier of the RNS-320 Neurostimulator battery to procure a raw material from an alternate supplier
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S099
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2025-08-18
- Decision code
- OK30
- Date received
- 2025-07-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for the approved supplier of the RNS-320 Neurostimulator battery to procure a raw material from an alternate supplier