PMA supplement
P050052 S057: RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC
FDA PMA supplement · 30-Day Notice · Merz North America, Inc.
Key facts
| Original PMA | P050052 |
|---|---|
| Supplement number | S057 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | RADIESSE 0.8CC, RADIESSE 1.5CC, RADIESSE 3.0 CC |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Merz North America, Inc. |
| Product code | LMH |
| Received date | Jul 23, 2014 |
| Decision date | Aug 19, 2014 |
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: