PMA
P020023: RESTYLANE INJECTABLE GEL
FDA PMA · Implant, dermal, for aesthetic use · Q-Med AB
Key facts
| PMA number | P020023 |
|---|---|
| Trade name | RESTYLANE INJECTABLE GEL |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Q-Med AB |
| Owner/operator | Q-MED AB |
| Product code | LMH |
| Approval date | Dec 12, 2003 |
| Docket number | 04M-0309 |
| Notice date | Jul 16, 2004 |
| Establishment registration | 9710154 |
| FEI number | 3003347293 |
At a glance
- 10–99 Supplements
- Oct 21, 2005 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- No Withdrawn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: