PMA P970003S226
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S226
- Product code
- LYJ
- Decision date
- 2019-09-05
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for Symmetry Model 8103 Generator for Depression, updates to MRI Labeling so that the Model 103 and Model 8103 Generator reflect the same expanded MRI conditions specified for the Model 105, Model 106 and Model 1000 Generator; and Model 3000 v1.5 Programmer Updates.
Current openFDA PMA Record#
- Device
- VNS Therapy System
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S226
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2019-09-05
- Decision code
- APPR
- Date received
- 2019-06-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Symmetry Model 8103 Generator for Depression, updates to MRI Labeling so that the Model 103 and Model 8103 Generator reflect the same expanded MRI conditions specified for the Model 105, Model 106 and Model 1000 Generator; and Model 3000 v1.5 Programmer Updates.