PMA supplement
P000025 S063: MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN)
FDA PMA supplement · Normal 180 Day Track · Med-El Corp.
Key facts
| Original PMA | P000025 |
|---|---|
| Supplement number | S063 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MED-EL COCHLEAR IMPLANT SYSTEMS (COMBI40+, PULSARCI100, SONATATI100, MED-EL CONCERT, & MED-EL CONCERT PIN) |
| Generic name | Implant, cochlear |
| Applicant | Med-El Corp. |
| Product code | MCM |
| Received date | Aug 10, 2012 |
| Decision date | Jun 6, 2013 |
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: