Identity
- Trade Name
- INSPIRE II UPPER AIRWAY STIMULATOR FDA PMA
- Generic Name
- Stimulator, hypoglossal nerve, implanted, apnea FDA PMA
Identifiers
- PMA Number
- P130008 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 Model 2740 Physician Programmer is an implanted hypoglossal nerve stimulator designed to treat moderate to severe obstructive sleep apnea (OSA) in adult patients aged 22 and older. This device is part of the Inspire Upper Airway Stimulation (UAS) System, which includes an implantable pulse generator, stimulation and sensing leads, and a patient programmer. It is classified as a Class III medical device under FDA regulations and is intended for patients who fail or cannot tolerate positive airway pressure (PAP) treatments such as CPAP or BiPAP.
The Model 2740 Physician Programmer is used in clinical settings for programming and adjusting the implanted stimulator system. It is a reusable device and is not sterile, requiring proper handling and maintenance as per manufacturer guidelines. The system is approved under FDA PMA (Premarket Approval) and is regulated under product code MNQ. Storage and usage must comply with FDA and manufacturer-specific instructions to ensure optimal performance and patient safety.
Frequently asked questions
What is the primary clinical use of the Model 2740 Physician Programmer in treating obstructive sleep apnea (OSA)?
The Model 2740 Physician Programmer is used in clinical settings to program and adjust the Inspire Upper Airway Stimulation (UAS) System, which includes an implanted hypoglossal nerve stimulator. It is intended for adult patients aged 22 and older with moderate to severe OSA (AHI ≥ 20 and ≤ 65) who have failed or cannot tolerate positive airway pressure (PAP) treatments like CPAP or BiPAP. The system stimulates the hypoglossal nerve to prevent airway collapse during sleep, targeting patients with incomplete concentric collapses at the soft palate level.
Is the Model 2740 Physician Programmer a single-use or reusable device, and what are the handling requirements?
The Model 2740 Physician Programmer is a reusable device and is not sterile. It requires proper handling and maintenance as outlined by the manufacturer to ensure reliability and patient safety. Since it is not sterile, it must be cleaned and stored according to Inspire Medical Systems’ guidelines to prevent contamination between uses.
What regulatory pathway was followed for approval of this device, and what is its classification under FDA regulations?
The Model 2740 Physician Programmer was approved through the FDA’s Premarket Approval (PMA) process, specifically under PMA number P130008. It is classified as a Class III medical device under FDA regulations, indicating it carries higher risk and requires rigorous pre-market approval due to its role in treating a serious condition like obstructive sleep apnea.
How does the Inspire UAS System differ from traditional PAP treatments like CPAP, and who is it intended for?
Unlike traditional PAP treatments (CPAP/BiPAP), which rely on external air pressure to keep airways open, the Inspire UAS System uses electrical stimulation of the hypoglossal nerve to prevent airway collapse. It is intended for adult patients 22+ years old who have moderate to severe OSA (AHI ≥ 20 and ≤ 65) but have failed or cannot tolerate PAP therapy—either due to insufficient usage (e.g., <4 hours/night) or unwillingness to use it. The system is not suitable for patients with complete concentric collapses at the soft palate.
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 | P130008 | Class III | Active |
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Manufacturer
- Manufacturer
- Inspire Medical Systems
Sources (1)
- FDA PMA P130008 24 fields · synced Sep 18, 2026