- Device
- SenTiva™ Model 1000 and SenTiva Duo™ Model 1000-D Generator Rhodium Reed Switch
- Applicant
- LivaNova USA, Inc.
- PMA number
- P970003
- Supplement
- S236
- Product code
- LYJ
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Decision date
- 2022-06-06
- Decision code
- APPR
- Date received
- 2022-04-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change to the reed switch (i.e., change from Durel to Rhodium reed switch) that is used in the Model 1000 and M1000-D Generators.