PMA
P200021: Neuro Cochlear Implant System
FDA PMA · Implant, cochlear · Oticon Medical
Key facts
| PMA number | P200021 |
|---|---|
| Trade name | Neuro Cochlear Implant System |
| Generic name | Implant, cochlear |
| Applicant | Oticon Medical |
| Owner/operator | DEMANT A/S |
| Product code | MCM |
| Approval date | Jun 23, 2021 |
| Docket number | 21M-0615 |
| Notice date | Jun 29, 2021 |
| Establishment registration | 3007367732 |
| FEI number | 3007367732 |
At a glance
- 10–99 Supplements
- Nov 4, 2022 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: