VNS THERAPY SYSTEM
FDA premarket approval P970003/S103 · decided 2008-12-19
Approval details
- PMA number
- P970003
- Supplement
- S103
- 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
- 2008-10-31
- Decision date
- 2008-12-19
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- APPROVAL FOR THE ADDITION OF A SOFTWARE ACCESSORY/TOOL REFERRED TO AS THE ¿GENERATOR FIELD UPGRADER¿ (GFU). THE GFU IS DESIGNED TO BE USED TO UPGRADE SOFTWARE IN THE DEMIPULSE, MODEL 103 AND DEMIPULSE DUO, MODEL 104 PULSE GENERATORS TO EITHER ENHANCE PRE-EXISTING FEATURES OR TO RESOLVE SOFTWARE ANOMALIES.
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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 |