VNS Therapy System
FDA premarket approval P970003/S248 · decided 2025-09-05
Approval details
- PMA number
- P970003
- Supplement
- S248
- 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
- 2025-08-06
- Decision date
- 2025-09-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for:1. VNS Therapy Epilepsy Physicians Manuals:Update to create a new Management of Depression as a Comorbidity section to inform physicians that depression is a common comorbidity for epilepsy patients and to follow standard medical practice for follow up with these patients and monitoring of their depressive symptoms. Document 26-0011-0100 (Epilepsy Manual; Appendix 1, page 117) New Section added to the Post-Implant Management Chapter: Follow-up Visits: Long-Term Follow Up Section
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |