PMA
P840024: NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI
FDA PMA · Implant, cochlear · Cochlear Americas
Key facts
| PMA number | P840024 |
|---|---|
| Trade name | NUCLEUS MULTICHANNEL IMPLANTABLE HEARING PROSTHESI |
| Generic name | Implant, cochlear |
| Applicant | Cochlear Americas |
| Owner/operator | COCHLEAR AMERICAS |
| Product code | MCM |
| Approval date | Oct 31, 1985 |
| Docket number | 85M-0524 |
| Notice date | Dec 9, 1985 |
| Establishment registration | 3005900820 |
| FEI number | 3005900820 |
At a glance
- 10–99 Supplements
- Sep 28, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: