- Device
- SenTiva™ Generator, SenTiva Duo™ Generator
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S243
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2024-03-15
- Decision code
- OK30
- Date received
- 2024-02-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to automate the dimensional inspections using the Keyence LM-1100 Image Dimension Measuring System during the receiving inspection for the VNS Therapy devices