PMA P100026S087
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- Product code
- PFN
- Decision date
- 2023-09-28
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval to add alternate cleaning equipment and solvent to degrease the Neurostimulator can and Ferrule.
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S087
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2023-09-28
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to add alternate cleaning equipment and solvent to degrease the Neurostimulator can and Ferrule.