PMA
P970051: NUCLEUS 24 COCHLEAR IMPLANT SYSTEM
FDA PMA · Implant, cochlear · Cochlear Americas
Key facts
| PMA number | P970051 |
|---|---|
| Trade name | NUCLEUS 24 COCHLEAR IMPLANT SYSTEM |
| Generic name | Implant, cochlear |
| Applicant | Cochlear Americas |
| Owner/operator | COCHLEAR AMERICAS |
| Product code | MCM |
| Approval date | Jun 25, 1998 |
| Docket number | 98M-0711 |
| Notice date | Sep 9, 1998 |
| Establishment registration | 3005900820 |
| FEI number | 3005900820 |
At a glance
- 100–999 Supplements
- Sep 28, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1,000+ 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: