VNS Therapy System
FDA premarket approval P970003/S245 · decided 2024-11-14
Approval details
- PMA number
- P970003
- Supplement
- S245
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VNS Therapy System
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2024-10-15
- Decision date
- 2024-11-14
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- VNS Therapy Physicians Manuals (Epilepsy and Depression): Update to the Warnings, Device Diagnostics, and General Troubleshooting sections to add information related to a Potential Loss of Function due to a stuck-closed reed switch. Additional update to the technical language to refer to the magnetic sensor more generally instead of specifying a reed switch to allow other technologies to be used without requiring additional labeling updates. VNS Therapy Patient Guides (Epilepsy and Depressio
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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 |