PMA
P140029: Restylane Refyne, Restylane Defyne
FDA PMA · Implant, dermal, for aesthetic use · Q-Med AB
Key facts
| PMA number | P140029 |
|---|---|
| Trade name | Restylane Refyne, Restylane Defyne |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Q-Med AB |
| Owner/operator | Q-MED AB |
| Product code | LMH |
| Approval date | Dec 9, 2016 |
| Docket number | 16M-4344 |
| Notice date | Dec 14, 2016 |
| Establishment registration | 9710154 |
| FEI number | 3003347293 |
At a glance
- 10–99 Supplements
- Sep 18, 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- No Withdrawn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: