Inspire II Upper Airway Stimulator
FDA premarket approval P130008/S063 · decided 2021-03-12
Approval details
- PMA number
- P130008
- Supplement
- S063
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Inspire II Upper Airway Stimulator
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2020-12-14
- Decision date
- 2021-03-12
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for:1) Updates to the System Implant Manual to include an alternative implant technique for the sensing lead ; and2) Updates to the MRI Guidelines in conjunction with the update to the System Implant Manual
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