PMA P970003S228
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- Product code
- LYJ
- Decision date
- 2020-01-31
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Make updates to the Electrical Test System used during the production of the Model 2000 Programming Wand.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S228
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2020-01-31
- Decision code
- OK30
- Date received
- 2019-10-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Make updates to the Electrical Test System used during the production of the Model 2000 Programming Wand.