PMA
P000015: NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM
FDA PMA · Implant, auditory brainstem · Cochlear Americas
Key facts
| PMA number | P000015 |
|---|---|
| Trade name | NUCLEUS 24 AUDITORY BRAINSTEM IMPLANT SYSTEM |
| Generic name | Implant, auditory brainstem |
| Applicant | Cochlear Americas |
| Owner/operator | COCHLEAR AMERICAS |
| Product code | MHE |
| Approval date | Oct 20, 2000 |
| Docket number | 00M-1659 |
| Notice date | Dec 12, 2000 |
| Establishment registration | 3005900820 |
| FEI number | 3005900820 |
At a glance
- 10–99 Supplements
- Sep 28, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: