PMA supplement
P000025 S104: MED-EL Cochlear Implant System
FDA PMA supplement · Panel Track · Med-El Corp.
Key facts
| Original PMA | P000025 |
|---|---|
| Supplement number | S104 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MED-EL Cochlear Implant System |
| Generic name | Implant, cochlear |
| Applicant | Med-El Corp. |
| Product code | MCM |
| Received date | Jul 30, 2018 |
| Decision date | Jul 19, 2019 |
| Docket number | 19M-3513 |
| Notice date | Jul 26, 2019 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: