PMA
P110033: JUVEDERM VOLUMA XC
FDA PMA · Implant, dermal, for aesthetic use · Allergan
Key facts
| PMA number | P110033 |
|---|---|
| Trade name | JUVEDERM VOLUMA XC |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Allergan |
| Owner/operator | AbbVie, Inc. |
| Product code | LMH |
| Approval date | Oct 22, 2013 |
| Docket number | 13M-1364 |
| Notice date | Nov 20, 2013 |
| Establishment registration | 2011068 |
| FEI number | 2011068 |
At a glance
- 10–99 Supplements
- Aug 28, 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- No Withdrawn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: