PMA P100026S081
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S081
- Product code
- PFN
- Decision date
- 2020-07-14
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval for an update to the custom integrated circuit (IC) of the RNS® Neurostimulator, from Cinco 1E to Cinco 1F.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S081
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2020-07-14
- Decision code
- APPR
- Date received
- 2020-04-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an update to the custom integrated circuit (IC) of the RNS® Neurostimulator, from Cinco 1E to Cinco 1F.