SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance
FDA premarket approval P970003/S244 · decided 2024-07-18
Approval details
- PMA number
- P970003
- Supplement
- S244
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2024-04-30
- Decision date
- 2024-07-18
- Days to decision
- 79 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for adding Automatic Recovery function, for addressing open anomalies, and for minor enhancements to the crash logging and variable handling within the firmware for the Sentiva Model 1000 and Model 1000-D Generators (SN >= 400,000).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Venous Return Cannulae (K250937) | LivaNova USA, Inc. | 2026-03-11 |
| RAP Femoral Venous Cannulae (K250283) | LivaNova USA, Inc. | 2025-07-10 |
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |