PMA supplement
P040024 S056: RESTYLANE L INJECTABLE GEL
FDA PMA supplement · Panel Track · Q-Med AB
Key facts
| Original PMA | P040024 |
|---|---|
| Supplement number | S056 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | RESTYLANE L INJECTABLE GEL |
| Generic name | Implant, dermal, for aesthetic use |
| Applicant | Q-Med AB |
| Product code | LMH |
| Received date | Jan 10, 2012 |
| Decision date | Aug 30, 2012 |
| Docket number | 12M-0968 |
| Notice date | Sep 12, 2012 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: