PMA
P890027: NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN
FDA PMA · Implant, cochlear · Cochlear Americas
Key facts
| PMA number | P890027 |
|---|---|
| Trade name | NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYS /CHILDREN |
| Generic name | Implant, cochlear |
| Applicant | Cochlear Americas |
| Owner/operator | COCHLEAR AMERICAS |
| Product code | MCM |
| Approval date | Jun 27, 1990 |
| Docket number | 90m-0222 |
| Notice date | Jul 27, 1990 |
| 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- No Withdrawn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: