PMA P100026S088
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- Product code
- PFN
- Decision date
- 2022-01-18
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval to modify the labeling for the NeuroPace® RNS® Neurostimulator model RNS-320 to provide updated estimates for battery longevity.
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S088
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2022-01-18
- Decision code
- APPR
- Date received
- 2021-10-28
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to modify the labeling for the NeuroPace® RNS® Neurostimulator model RNS-320 to provide updated estimates for battery longevity.