PMA P100026S098
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S098
- Product code
- PFN
- Decision date
- 2025-05-12
- Classification
- Neurology
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- new polyethylene bulk material from new supplier for the battery used within the RNS-320 system
Current openFDA PMA Record#
- Device
- NEUROPACE RNS SYSTEM
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S098
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2025-05-12
- Decision code
- APPR
- Date received
- 2025-03-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- new polyethylene bulk material from new supplier for the battery used within the RNS-320 system