Stimulator, Hypoglossal Nerve, Implanted, Apnea
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- aura6000 system
- PMA Number
- P250013
- Device Class
- FDA Class 3
- Product Code
- MNQ
- Generic Name
- Stimulator, hypoglossal nerve, implanted, apnea
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 18, 2026
- Date Received
- April 25, 2025
- Expedited Review
- N
Advisory Committee 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 = 65. The aura6000 system is intended for patients who failed, do not tolerate, or are ineligible to be treated with current standard of care treatments such as positive airway pressure (PAP), oral appliances (e.g. mandibular advancement device), or pharmacotherapy. PAP failure is defined as an inability to eliminate OSA (AHI of greater than 15 despite PAP usage), and PAP intolerance is defined as: Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or Unwillingness to use PAP (e.g., a patient returns the PAP system after attempting to use it).
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MNQ | Stimulator, Hypoglossal Nerve, Implanted, Apnea | FDA class 3 | Unknown |