PMA supplement
P000015 S042: Nucleus ABI541 Auditory Brainstem Implant
FDA PMA supplement · 30-Day Notice · Cochlear Americas
Key facts
| Original PMA | P000015 |
|---|---|
| Supplement number | S042 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Nucleus ABI541 Auditory Brainstem Implant |
| Generic name | Implant, auditory brainstem |
| Applicant | Cochlear Americas |
| Product code | MHE |
| Received date | Nov 13, 2019 |
| Decision date | Dec 13, 2019 |
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: