PMA supplement
P970051 S219: Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I
FDA PMA supplement · 30-Day Notice · Cochlear Americas
Key facts
| Original PMA | P970051 |
|---|---|
| Supplement number | S219 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Nucleus CI522 Cochlear Implant, Nucleus CI532 Cochlear Implant, Nucleus CI622 Cochlear Implant, Nucleus CI624 Cochlear I |
| Generic name | Implant, cochlear |
| Applicant | Cochlear Americas |
| Product code | MCM |
| Received date | Jun 15, 2023 |
| Decision date | Jul 14, 2023 |
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: