Inspire Upper Airway Stimulation (UAS) System
FDA premarket approval P130008/S098 · decided 2024-08-01
Approval details
- PMA number
- P130008
- Supplement
- S098
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Inspire Upper Airway Stimulation (UAS) System
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2023-06-30
- Decision date
- 2024-08-01
- Days to decision
- 398 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- approval for a new implant device, the Inspire V Model 3150 Implantable Pulse Generator (IPG). The Model 3150 IPG is the new version of the currently approved Model 3028
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