PMA P100026S091
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S091
- Product code
- PFN
- Decision date
- 2022-12-29
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Approval to use a second contract sterilizer for the ethylene oxide (EO) sterilization of RNS System products.
Current openFDA PMA Record#
- Device
- NeuroPace® RNS® System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S091
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2022-12-29
- Decision code
- APPR
- Date received
- 2022-09-26
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to use a second contract sterilizer for the ethylene oxide (EO) sterilization of RNS System products.