PMA supplement
P130016 S012: NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM
FDA PMA supplement · Normal 180 Day Track · Cochlear Americas
Key facts
| Original PMA | P130016 |
|---|---|
| Supplement number | S012 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | NUCLEUS HYBRID COCHLEAR IMPLANT SYSTEM |
| Generic name | Cochlear implant with combined electrical stimulation and acoustic amplification |
| Applicant | Cochlear Americas |
| Product code | PGQ |
| Received date | Nov 23, 2015 |
| Decision date | Jul 8, 2016 |
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: