PMA
P090016: BELOTERO BALANCE
FDA PMA · Implant, dermal, for aesthetic use · Merz North America, Inc.
Key facts
| PMA number | P090016 |
|---|---|
| Trade name | BELOTERO BALANCE |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Merz North America, Inc. |
| Owner/operator | Merz North America, Inc. |
| Product code | LMH |
| Approval date | Nov 14, 2011 |
| Docket number | 11M-0832 |
| Notice date | Nov 22, 2011 |
| Establishment registration | 2135225 |
| FEI number | 3003407669 |
At a glance
- 10–99 Supplements
- May 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: