- Device
- VNS THERAPY PULSE GENERATOR, LEAD AND PATIENT KIT
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S063
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2006-06-29
- Decision code
- APPR
- Date received
- 2006-01-27
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING HARMONIZATION AND MODULARIZATION FOR PHYSICIAN, PULSE GENERATOR, LEAD AND PATIENT KIT LABELING.