PMA
P000029: DEFLUX INJECTABLE GEL
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Palette Life Sciences
Key facts
| PMA number | P000029 |
|---|---|
| Trade name | DEFLUX INJECTABLE GEL |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Palette Life Sciences |
| Owner/operator | Palette Life Sciences |
| Product code | LNM |
| Approval date | Sep 24, 2001 |
| Docket number | 01M-0439 |
| Notice date | Oct 1, 2001 |
| Establishment registration | 3014909464 |
| FEI number | 3014909464 |
At a glance
- 10–99 Supplements
- May 31, 2024 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- No Withdrawn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: