aura6000 system
FDA premarket approval P250013 · decided 2026-03-18
Approval details
- PMA number
- P250013
- Trade name
- aura6000 system
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- LivaNova USA, Inc.
- Date received
- 2025-04-25
- Decision date
- 2026-03-18
- Days to decision
- 327 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Houston, TX
- Statement
- Approval for the aura6000 system, which includes the Implantable Pulse Generator Model #100.0100, Lead Models #300.0100 (25cm) and #300.0200 (33cm), Remote Control & Charger Model #500.0100, Charging Antenna Model #500.0300, aura Clinical Manager Model #700.0100, Torque Wrench, and Suture Sleeve. The device is indicated for the reduction of apneas, hypopneas, or both in adult patients with moderate to severe obstructive sleep apnea (OSA), defined as an apnea-hypopnea index (AHI) of = 15 and = 6
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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 |