FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Hypoglossal Nerve, Implanted, Apnea
PMA: P130008
·
Supplement: S137
·
Decision Mar 13, 2026
Classifications
1
FEI Numbers
0
Registration Numbers
0
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Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- Model 3150 Implantable Pulse Generator (IPG)
- PMA Number
- P130008
- Supplement Number
- S137
- Device Class
- FDA Class 3
- Product Code
- MNQ
- Generic Name
- Stimulator, hypoglossal nerve, implanted, apnea
- Medical Specialty
- Unknown
- Advisory Committee
- Anesthesiology
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- March 13, 2026
- Date Received
- February 18, 2026
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for an additional sterilization chamber at the current validated sterilization vendor, Steris Applied Sterilization Technologies (AST), for the Model 3150 Implantable Pulse Generator (IPG).
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 |