PMA P970003S237
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S237
- Product code
- LYJ
- Decision date
- 2023-01-18
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Introduce a new parallel-gap welding system and its associated parameter changes used in the production of the M303 and M304 Leads.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S237
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2023-01-18
- Decision code
- OK30
- Date received
- 2022-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce a new parallel-gap welding system and its associated parameter changes used in the production of the M303 and M304 Leads.