PMA P970003
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S237
- Product code
- LYJ
- Decision date
- 2026-10-02
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- approval for change in the battery voltage offset in battery longevity calculation to be applied over 15% of battery usage instead of 7.5%.
Current openFDA PMA Record#
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S254
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2026-10-02
- Decision code
- APPR
- Date received
- 2026-03-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for change in the battery voltage offset in battery longevity calculation to be applied over 15% of battery usage instead of 7.5%.