VNS Therapy System
FDA premarket approval P970003/S226 · decided 2019-09-05
Approval details
- PMA number
- P970003
- Supplement
- S226
- 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
- 2019-06-10
- Decision date
- 2019-09-05
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for Symmetry Model 8103 Generator for Depression, updates to MRI Labeling so that the Model 103 and Model 8103 Generator reflect the same expanded MRI conditions specified for the Model 105, Model 106 and Model 1000 Generator; and Model 3000 v1.5 Programmer Updates.
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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 |