PMA supplement
P130008 S063: Inspire II Upper Airway Stimulator
FDA PMA supplement · Normal 180 Day Track · Inspire Medical Systems
Key facts
| Original PMA | P130008 |
|---|---|
| Supplement number | S063 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | 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 |
| Product code | MNQ |
| Received date | Dec 14, 2020 |
| Decision date | Mar 12, 2021 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: