PMA
P830069: 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN
FDA PMA · Implant, cochlear · Cochlear Americas
Key facts
| PMA number | P830069 |
|---|---|
| Trade name | 3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN |
| Generic name | Implant, cochlear |
| Applicant | Cochlear Americas |
| Owner/operator | COCHLEAR AMERICAS |
| Product code | MCM |
| Approval date | Nov 26, 1984 |
| Docket number | 84M-0395 |
| Notice date | Dec 24, 1984 |
| Establishment registration | 3005900820 |
| FEI number | 3005900820 |
At a glance
- 1–9 Supplements
- May 22, 1986 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: