Inspire Upper Airway Stimulation (UAS)
FDA premarket approval P130008/S076 · decided 2022-07-01
Approval details
- PMA number
- P130008
- Supplement
- S076
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire Upper Airway Stimulation (UAS)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-11-02
- Decision date
- 2022-07-01
- Days to decision
- 241 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for additional MR scanning conditions using a 1.5T full body coil scanner for Model 3028 IPG, Model 4323, Model 4340 and Model 4063 leads
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