PMA
P960058: CLARION MULTI-STRATEGY COCHLEAR IMPLANT
FDA PMA · Implant, cochlear · Advanced Bionics
Key facts
| PMA number | P960058 |
|---|---|
| Trade name | CLARION MULTI-STRATEGY COCHLEAR IMPLANT |
| Generic name | Implant, cochlear |
| Applicant | Advanced Bionics |
| Owner/operator | Advanced Bionics LLC |
| Product code | MCM |
| Approval date | Jun 26, 1997 |
| Docket number | 97M-0396 |
| Notice date | Sep 23, 1997 |
| Establishment registration | 3009762645 |
| FEI number | 1000220815 |
At a glance
- 100–999 Supplements
- Sep 18, 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- No Withdrawn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: