PMA P970003S234
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S234
- Product code
- LYJ
- Decision date
- 2021-02-22
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for changes to the M3000 Programming Software (from M3000 v1.6.1.9 to M3000 v1.6.2.0).
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S234
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2021-02-22
- Decision code
- APPR
- Date received
- 2020-11-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for changes to the M3000 Programming Software (from M3000 v1.6.1.9 to M3000 v1.6.2.0).