FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Stimulator, Hypoglossal Nerve, Implanted, Apnea
PMA: P130008
·
Supplement: S029
·
Decision May 11, 2018
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
- S029
- 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
- May 11, 2018
- Date Received
- November 14, 2017
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - PAS
- Expedited Review
- N
Advisory Committee Statement
Approval for updates to the labeling with the results of the Extended Follow Up of the Premarket Cohort post approval study.
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 |