VNS THERAPY SYSTEM
FDA premarket approval P970003/S247 · decided 2025-05-02
Approval details
- PMA number
- P970003
- Supplement
- S247
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS THERAPY SYSTEM
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2025-03-12
- Decision date
- 2025-05-02
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- approval for replacement of the reed switch with giant magnetoresistor sensor for utilizing magnet mode within the implantable pulse generator (Model M1000 and M1000-D) as a corrective action for recall Z-1072-2025
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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 |