SenTiva Model 1000 and SenTiva Duo Model 1000-D Generator Rhodium Reed Switch
FDA premarket approval P970003/S236 · decided 2022-06-06
Approval details
- PMA number
- P970003
- Supplement
- S236
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SenTiva Model 1000 and SenTiva Duo Model 1000-D Generator Rhodium Reed Switch
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2022-04-11
- Decision date
- 2022-06-06
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- 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.
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| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
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