Stimulator, Hypoglossal Nerve, Implanted, Apnea
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- Inspire Upper Airway Stimulation
- PMA Number
- P130008
- Supplement Number
- S089
- 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 20, 2023
- Date Received
- August 19, 2022
- Supplement Type
- Panel Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
- Docket Number
- 23M-1126
Advisory Committee Statement
Approval for the Inspire Upper Airway Stimulation (UAS) the device is used to treat a subset of pediatric Down syndrome patients between the age of 13-18 with severe OSA (apnea-hypopnea index [AHI] of greater than or equal to 10 and less than or equal to 50) who: 1) Do not have complete concentric collapse at the soft palate level;2) Are contraindicated for or not effectively treated by adenotonsillectomy; 3) Have been confirmed to fail, or cannot tolerate positive airway pressure (PAP) therapy despite attempts to improve compliance; and4) Have followed standard of care in considering all other alternative/adjunct therapies. PAP failure is defined as an inability to eliminate OSA, and PAP intolerance is defined as: a. Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night), or b. Unwillingness to use PAP (for example, 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 |