PMA P970003S253
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S253
- Product code
- LYJ
- Decision date
- 2026-03-04
- Classification
- Neurology
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- approval to utilize an alternate sterilizer to sterilize all VNS devices and products
Current openFDA PMA Record#
- Device
- VNS Therapy® System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S253
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2026-03-04
- Decision code
- OK30
- Date received
- 2026-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to utilize an alternate sterilizer to sterilize all VNS devices and products