VNS Therapy System
FDA premarket approval P970003/S239 · decided 2023-03-02
Approval details
- PMA number
- P970003
- Supplement
- S239
- 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
- 2023-02-01
- Decision date
- 2023-03-02
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for updates to the warning and precaution sections in the VNS Therapy Physicians Manuals for both Epilepsy and Depression regarding a clearer message directing the reader to view and reference the LivaNova magnetic resonance imaging (MRI) guidelines for any considerations for MRI scans in patients with the VNS Therapy System.
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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 |