PMA P100026S050
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S050
- Product code
- PFN
- Decision date
- 2017-12-09
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval for modifications to the printed circuit assembly of the RNS® Neurostimulator model RNS-320 to remove Long Range Telemetry (LRT) components.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S050
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2017-12-09
- Decision code
- APPR
- Date received
- 2017-09-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for modifications to the printed circuit assembly of the RNS® Neurostimulator model RNS-320 to remove Long Range Telemetry (LRT) components.