PMA P100026S093
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S093
- Product code
- PFN
- Decision date
- 2023-02-17
- Classification
- Neurology
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Modify the Automated Test Equipment hardware, software and database to improve the yield of components used in the production of the RNS Neurostimulators.
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S093
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2023-02-17
- Decision code
- OK30
- Date received
- 2023-01-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the Automated Test Equipment hardware, software and database to improve the yield of components used in the production of the RNS Neurostimulators.