PMA supplement
P960058 S167: HiResolution™ Bionic Ear System
FDA PMA supplement · Panel Track · Advanced Bionics
Key facts
| Original PMA | P960058 |
|---|---|
| Supplement number | S167 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | HiResolution™ Bionic Ear System |
| Generic name | Implant, cochlear |
| Applicant | Advanced Bionics |
| Product code | MCM |
| Received date | Jan 29, 2025 |
| Decision date | Jul 22, 2026 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: