PMA P970003S233
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- Product code
- LYJ
- Decision date
- 2022-08-12
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for MR-conditional labeling for the VNS Model 1000-D SenTiva Duo Generator.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S233
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2022-08-12
- Decision code
- APPR
- Date received
- 2020-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for MR-conditional labeling for the VNS Model 1000-D SenTiva Duo Generator.