Identity
- Trade Name
- aura6000 system FDA PMA
- Generic Name
- Stimulator, hypoglossal nerve, implanted, apnea FDA PMA
Identifiers
- PMA Number
- P250013 FDA PMA
- FDA Product Code
- MNQ FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Anesthesiology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The aura6000 System is an Implanted Hypoglossal Nerve Stimulator, classified under the generic name ‘Stimulator, hypoglossal nerve, implanted, apnea.’ It is designed to reduce apneas and hypopneas in adult patients with moderate to severe obstructive sleep apnea (OSA), defined by an apnea-hypopnea index (AHI) of 15 or greater. The device delivers targeted nerve stimulation to promote upper airway patency during sleep, addressing patients who have failed, are intolerant of, or are ineligible for standard treatments like positive airway pressure (PAP).
The system comprises multiple components, including the Implantable Pulse Generator (Model #100.0100), leads (Models #300.0100 for 25cm and #300.0200 for 33cm), a Remote Control & Charger (Model #500.0100), Charging Antenna (Model #500.0300), aura Clinical Manager (Model #700.0100), and ancillary tools like a Torque Wrench and Suture Sleeve. Intended for surgical implantation, the device is regulated under FDA Premarket Approval (PMA P250013) and falls under Class III medical device classification (Product Code MNQ). Sterility and single-use specifications are not explicitly stated in the provided data.
Frequently asked questions
What specific patient population is the aura6000™ system designed to treat, and what criteria define their eligibility?
The aura6000™ system is designed for adult patients with moderate to severe obstructive sleep apnea (OSA), defined by an apnea-hypopnea index (AHI) of 15 or greater. It is intended for patients who have failed, are intolerant of, or are ineligible for standard treatments like positive airway pressure (PAP), oral appliances, or pharmacotherapy. PAP failure is determined if the patient still has an AHI greater than 15 despite using PAP, while intolerance is defined as using PAP fewer than 5 nights per week for less than 4 hours per night or unwillingness to continue use.
How is the aura6000™ system supplied, and what components are included in the full package?
The aura6000™ system includes several key components: the Implantable Pulse Generator (Model #100.0100), leads in two lengths (25cm, Model #300.0100, and 33cm, Model #300.0200), a Remote Control & Charger (Model #500.0100), a Charging Antenna (Model #500.0300), the aura Clinical Manager software (Model #700.0100), and ancillary surgical tools like a Torque Wrench and Suture Sleeve. These components work together to deliver targeted hypoglossal nerve stimulation for OSA treatment.
Is the aura6000™ system intended for single-use or reusable applications, and what are the sterility considerations?
The provided data does not explicitly state whether the aura6000™ system components are single-use or reusable. However, implanted devices like the Implantable Pulse Generator and leads are typically designed for permanent implantation, while external components such as the Remote Control & Charger and Charging Antenna may be reusable. Sterility specifications are not detailed, so users should follow manufacturer guidelines for handling and preparation to ensure safety and compliance.
What regulatory pathway was followed for the approval of the aura6000™ system, and what classification does it hold?
The aura6000™ system was approved through the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P250013. It is classified as a Class III medical device under Product Code MNQ, indicating it carries higher regulatory scrutiny due to its intended use as an implanted device for treating obstructive sleep apnea.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P250013 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- LivaNova USA, Inc.
Sources (1)
- FDA PMA P250013 23 fields · synced Sep 18, 2026