PMA P970003S252
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S252
- Product code
- LYJ
- Decision date
- 2025-12-17
- Classification
- Neurology
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- to implement a new burn-in process for the MSP430 Microcontrollers at a supplier for the Models 100 and 1000-D, SenTiva Implantable Pulse Generators
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S252
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a new burn-in process for the MSP430 Microcontrollers at a supplier for the Models 100 and 1000-D, SenTiva Implantable Pulse Generators