PMA
P050037: RADIESSE 1.3CC AND 0.3CC
FDA PMA · Implant, dermal, for aesthetic use · Merz North America, Inc.
Key facts
| PMA number | P050037 |
|---|---|
| Trade name | RADIESSE 1.3CC AND 0.3CC |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Merz North America, Inc. |
| Owner/operator | Merz North America, Inc. |
| Product code | LMH |
| Approval date | Dec 22, 2006 |
| Docket number | 07M-0006 |
| Notice date | Jan 17, 2007 |
| Establishment registration | 2135225 |
| FEI number | 3003407669 |
At a glance
- 100–999 Supplements
- Jun 26, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: