PMA P970003S235
- Device
- VNS Therapy PerenniaDURA Model 303 Lead
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S235
- Product code
- LYJ
- Decision date
- 2022-03-09
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Add a new inspection of the bifurcated tubing wall thickness associated with the M303 Lead.
Current openFDA PMA Record#
- Device
- VNS Therapy PerenniaDURA Model 303 Lead
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S235
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2022-03-09
- Decision code
- OK30
- Date received
- 2022-02-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new inspection of the bifurcated tubing wall thickness associated with the M303 Lead.