VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand
FDA premarket approval P970003/S241 · decided 2023-09-15
Approval details
- PMA number
- P970003
- Supplement
- S241
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand
- Generic name
- Stimulator, autonomic nerve, implanted for epilepsy
- Applicant
- LivaNova USA, Inc.
- Date received
- 2023-04-03
- Decision date
- 2023-09-15
- Days to decision
- 165 days
- Decision code
- APPR
- Product code
- LYJ
- Advisory committee
- Neurology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the new Model 3100 v1.0 Programmer Software, updated M2000 v1.1.2.2 Programming Wand Firmware, and the new Digital Products Platform.
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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 |