PMA supplement
P960058 S103: HIRESOLUTION BIONIC EAR SYSTEM
FDA PMA supplement · 135 Review Track For 30-Day Notice · Advanced Bionics
Key facts
| Original PMA | P960058 |
|---|---|
| Supplement number | S103 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | HIRESOLUTION BIONIC EAR SYSTEM |
| Generic name | Implant, cochlear |
| Applicant | Advanced Bionics |
| Product code | MCM |
| Received date | Jul 17, 2013 |
| Decision date | Dec 24, 2013 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: