PMA
P000025: COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA PMA · Implant, cochlear · Med-El Corp.
Key facts
| PMA number | P000025 |
|---|---|
| Trade name | COMBI 40+ COCHLEAR IMPLANT SYSTEM |
| Generic name | Implant, cochlear |
| Applicant | Med-El Corp. |
| Owner/operator | MED-EL ELEKTROMEDIZINISCHE GERAETE GmbH |
| Product code | MCM |
| Approval date | Aug 20, 2001 |
| Docket number | 02M-0006 |
| Notice date | Jan 11, 2002 |
| Establishment registration | 1066702 |
| FEI number | 3003370917 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: