PMA P970003S225
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- Product code
- LYJ
- Decision date
- 2020-03-20
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for a New Multi-Product Sales Packaging Kit and Alternate Universal Inner Generator Medical Tray.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S225
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2020-03-20
- Decision code
- APPR
- Date received
- 2019-05-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a New Multi-Product Sales Packaging Kit and Alternate Universal Inner Generator Medical Tray.