PMA
P130008: INSPIRE II UPPER AIRWAY STIMULATOR
FDA PMA · Stimulator, hypoglossal nerve, implanted, apnea · Inspire Medical Systems
Key facts
| PMA number | P130008 |
|---|---|
| Trade name | INSPIRE II UPPER AIRWAY STIMULATOR |
| Generic name | Stimulator, hypoglossal nerve, implanted, apnea |
| Applicant | Inspire Medical Systems |
| Owner/operator | Inspire Medical Systems Inc. |
| Product code | MNQ |
| Approval date | Apr 30, 2014 |
| Docket number | 14M-0690 |
| Notice date | May 29, 2014 |
| Establishment registration | 3007666314 |
| FEI number | 3007666314 |
At a glance
- 100–999 Supplements
- Aug 28, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: