Stimulator, Hypoglossal Nerve, Implanted, Apnea
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- INSPIRE II UPPER AIRWAY STIMULATOR
- PMA Number
- P130008
- 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
- April 30, 2014
- Date Received
- May 1, 2013
- Expedited Review
- N
- Docket Number
- 14M-0690
Advisory Committee Statement
APPROVAL FOR THE INSPIRE UPPER AIRWAY STIMULATION (UAS) SYSTEM, WHICH INCLUDES THE MODEL 3024 IMPLANTABLE PULSE GENERATOR, THE MODEL 4063 STIMULATION LEAD, THE MODEL 4323 SENSING LEAD, THE MODEL 2740PHYSICIAN PROGRAMMER, AND THE MODEL 3032 PATIENT PROGRAMMER. THE DEVICE IS USED TO TREAT A SUBSET OF PATIENTS WITH MODERATE TO SEVERE OBSTRUCTIVE SLEEP APNEA (OSA) (APNEA-HYPOPNEA INDEX [AHI] OF GREATER OR EQUAL TO 20 AND LESS THAN OR EQUAL TO 65). INSPIRE UAS IS USED IN ADULT PATIENTS 22 YEARS OF AGE AND OLDER WHO HAVE BEEN CONFIRMED TO FAIL OR CANNOT TOLERATE POSITIVE AIRWAY PRESSURE (PAP) TREATMENTS (SUCH AS CONTINUOUS POSITIVE AIRWAY PRESSURE [CPAP] OR BILEVEL POSITIVE AIRWAY PRESSURE [BPAP] MACHINES) AND WHO DO NOT HAVE A COMPLETE CONCENTRIC COLLAPSE AT THE SOFT PALATE LEVEL. PAP FAILURE IS DEFINED AS AN INABILITY TO ELIMINATE OSA (AHI OF GREATER THAN 20 DESPITE PAP USAGE) AND PAP INTOLERANCE IS DEFINED AS: 1) INABILITY TO USE PAP (GREATER THAN 5 NIGHTS PER WEEK OF USAGE; USAGE DEFINED AS GREATER THAN 4 HOURS OF USE PER NIGHT); OR 2) 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 |