PMA P970003S221
- Device
- SenTiva Model 1000 Generator
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S221
- Product code
- LYJ
- Decision date
- 2019-03-27
- Classification
- Stimulator, Autonomic Nerve, Implanted For Epilepsy
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Approval order statement
- Approval for firmware updates of the Model 1000 Generator.
Current openFDA PMA Record#
- Device
- SenTiva Model 1000 Generator
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S221
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2019-03-27
- Decision code
- APPR
- Date received
- 2018-12-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for firmware updates of the Model 1000 Generator.