PMA supplement
P050052 S049: RADIESSE INJECTABLE IMPLANT
FDA PMA supplement · Panel Track · Merz North America, Inc.
Key facts
| Original PMA | P050052 |
|---|---|
| Supplement number | S049 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | RADIESSE INJECTABLE IMPLANT |
| Generic name | Implant, dermal, for aesthetic use in the hands |
| Applicant | Merz North America, Inc. |
| Product code | PKY |
| Received date | Dec 2, 2013 |
| Decision date | Jun 4, 2015 |
| Docket number | 15M-2078 |
| Notice date | Jun 5, 2015 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: