PMA supplement
P050037 S028: RADIESSE INJECTABLE IMPLANT
FDA PMA supplement · Normal 180 Day Track No User Fee · Merz North America, Inc.
Key facts
| Original PMA | P050037 |
|---|---|
| Supplement number | S028 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | RADIESSE INJECTABLE IMPLANT |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Merz North America, Inc. |
| Product code | LMH |
| Received date | Mar 30, 2011 |
| Decision date | Jun 20, 2012 |
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: