PMA supplement
P090018 S041: Esteem® Totally Implantable Hearing System
FDA PMA supplement · Normal 180 Day Track No User Fee · Envoy Medical Corporation
Key facts
| Original PMA | P090018 |
|---|---|
| Supplement number | S041 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | Esteem® Totally Implantable Hearing System |
| Generic name | Implant, hearing, active, middle ear, totally implanted |
| Applicant | Envoy Medical Corporation |
| Product code | OAF |
| Received date | Mar 23, 2022 |
| Decision date | Aug 24, 2022 |
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: