Inspire® Upper Airway Stimulation (UAS)
FDA premarket approval P130008/S115 · decided 2024-12-10
Approval details
- PMA number
- P130008
- Supplement
- S115
- 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
- 2024-11-14
- Decision date
- 2024-12-10
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- MNQ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Update to the battery tab weld fixture that is used by Inspires final device manufacturer, Osypka Medtec Inc. (OMI). A visual inspection was added as a result of this change
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.