PMA
P250013: aura6000™ system
FDA PMA · Stimulator, hypoglossal nerve, implanted, apnea · LivaNova USA, Inc.
Key facts
| PMA number | P250013 |
|---|---|
| Trade name | aura6000™ system |
| Generic name | Stimulator, hypoglossal nerve, implanted, apnea |
| Applicant | LivaNova USA, Inc. |
| Owner/operator | LivaNova USA, Inc. |
| Product code | MNQ |
| Approval date | Mar 18, 2026 |
| Establishment registration | 1644487 |
| FEI number | 1000117004 |
At a glance
- 1–9 Supplements
- Jun 18, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: