PMA
P240022: EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM
FDA PMA · Implant, dermal, for aesthetic use · Symatese
Key facts
| PMA number | P240022 |
|---|---|
| Trade name | EVOLYSSE™ SMOOTH and EVOLYSSE™ FORM |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Symatese |
| Owner/operator | Symatese |
| Product code | LMH |
| Approval date | Feb 13, 2025 |
| Docket number | 25M-0437 |
| Establishment registration | 3003672980 |
| FEI number | 3003672980 |
At a glance
- 1–9 Supplements
- Feb 27, 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- No Withdrawn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: