PMA P970003S211
- Device
- VNS Therapy Model 3000 Programmer
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S211
- Product code
- LYJ
- Decision date
- 2017-10-03
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for the introduction of the Model3000 Programmer into interstate commerce.
Current openFDA PMA Record#
- Device
- VNS Therapy Model 3000 Programmer
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S211
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2017-10-03
- Decision code
- APPR
- Date received
- 2017-05-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the introduction of the Model3000 Programmer into interstate commerce.