PMA P100026S049
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S049
- Product code
- PFN
- Decision date
- 2017-05-02
- Classification
- Implanted Brain Stimulator For Epilepsy
- Generic name
- Implanted brain stimulator for epilepsy
- Approval order statement
- Add alternate equipment for thermoforming of outer tray device packaging.
Current openFDA PMA Record#
- Device
- NeuroPace RNS System
- Applicant
- NeuroPace, Inc.
- PMA number
- P100026
- Supplement
- S049
- Product code
- PFN
- Generic name
- Implanted brain stimulator for epilepsy
- Decision date
- 2017-05-02
- Decision code
- OK30
- Date received
- 2017-04-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate equipment for thermoforming of outer tray device packaging.