FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Hypoglossal Nerve, Implanted, Apnea
PMA: P130008
·
Supplement: S024
·
Decision Jun 7, 2017
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- Inspire Medical Systems Model 3028 Implantable Pulse Generator
- PMA Number
- P130008
- Supplement Number
- S024
- 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
- June 7, 2017
- Date Received
- May 8, 2017
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Changes to the final functional testing of the Model 3028 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 |