FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Hypoglossal Nerve, Implanted, Apnea
PMA: P130008
·
Supplement: S008
·
Decision Aug 24, 2015
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- INSPIRE UPPER AIRWAY STIMULATION THERAPY
- PMA Number
- P130008
- Supplement Number
- S008
- 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
- August 24, 2015
- Date Received
- May 27, 2015
- Supplement Type
- Real-Time Process
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR EXTENSION OF THE SHELF LIFE OF THE MODEL 3024 IMPLANTABLE PULSE GENERATOR (IPG) TO 3 YEARS.
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 |