PMA supplement
P130016 S038: Hybrid L24 CI System
FDA PMA supplement · Normal 180 Day Track No User Fee · Cochlear Americas
Key facts
| Original PMA | P130016 |
|---|---|
| Supplement number | S038 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Hybrid L24 CI System |
| Generic name | Cochlear implant with combined electrical stimulation and acoustic amplification |
| Applicant | Cochlear Americas |
| Product code | PGQ |
| Received date | Jun 7, 2019 |
| Decision date | Dec 4, 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: