- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S095
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2024-08-13
- Decision code
- OK30
- Date received
- 2024-07-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement supplier process changes at the Integer, which include introducing automation for the lubricant application during the initial part-forming step; and bringing in-house the previously outsourced annealing process, which the Integer originally developed, with no changes to the annealing recipe, tooling, materials, or specifications