FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Stimulator, Hypoglossal Nerve, Implanted, Apnea
PMA: P130008
·
Supplement: S075
·
Decision Nov 3, 2021
Classifications
1
FEI Numbers
10
Registration Numbers
10
Basic Information
- Device Name
- Stimulator, Hypoglossal Nerve, Implanted, Apnea
- Trade Name
- Inspire Model 4340 Respiratory Sensing Lead
- PMA Number
- P130008
- Supplement Number
- S075
- 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
- November 3, 2021
- Date Received
- October 7, 2021
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Additional weld equipment, inspections and rework steps in the manufacturing of the Inspire model 4340 Respiratory Sensing Lead.
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 |