Inspire Upper Airway Stimulation (UAS)
FDA premarket approval P130008/S067 · decided 2021-06-24
Approval details
- PMA number
- P130008
- Supplement
- S067
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Inspire Upper Airway Stimulation (UAS)
- Generic name
- Stimulator, hypoglossal nerve, implanted, apnea
- Applicant
- Inspire Medical Systems
- Date received
- 2021-05-25
- Decision date
- 2021-06-24
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Modifications to the strain relief molding tool used to manufacture power and antenna cable assemblies for the Model 2740 Programmer Cable.
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