PMA P100026S086
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S086
- Product code
- PFN
- Decision date
- 2021-05-07
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Modify the Automatic Test Equipment (ATE) hardware, software and database to improve yield of components of the RNS Neurostimulators.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S086
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2021-05-07
- Decision code
- OK30
- Date received
- 2021-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the Automatic Test Equipment (ATE) hardware, software and database to improve yield of components of the RNS Neurostimulators.