PMA supplement
P000029 S098: Deflux® Injectable Gel
FDA PMA supplement · Special (Immediate Track) · Palette Life Sciences
Key facts
| Original PMA | P000029 |
|---|---|
| Supplement number | S098 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Deflux® Injectable Gel |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Palette Life Sciences |
| Product code | LNM |
| Received date | May 1, 2024 |
| Decision date | May 31, 2024 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: