PMA P970003S250
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S250
- Product code
- LYJ
- Decision date
- 2025-09-12
- Classification
- Neurology
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- to implement software programming updates for the Model 8103 IPGs
Current openFDA PMA Record#
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S250
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2025-09-12
- Decision code
- OK30
- Date received
- 2025-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement software programming updates for the Model 8103 IPGs