PMA P970003S210
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S210
- 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 Model 1000 Generator and the Model 2000 Programming Wand into interstate commerce as well as updated MRI Conditional Labeling for the VNS system.
Current openFDA PMA Record#
- Device
- VNS THERAPY SYSTEM
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S210
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2017-10-03
- Decision code
- APPR
- Date received
- 2017-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the introduction of the Model 1000 Generator and the Model 2000 Programming Wand into interstate commerce as well as updated MRI Conditional Labeling for the VNS system.