PMA P970003S230
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S230
- Product code
- LYJ
- Decision date
- 2020-01-29
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Incorporate a temporary manufacturing software screening test that detects devices susceptible to GC5 errata.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S230
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2020-01-29
- Decision code
- OK30
- Date received
- 2019-12-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Incorporate a temporary manufacturing software screening test that detects devices susceptible to GC5 errata.