PMA
P100014: SOLESTA INJECTABLE GEL
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Palette Life Sciences
Key facts
| PMA number | P100014 |
|---|---|
| Trade name | SOLESTA 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 | May 27, 2011 |
| Docket number | 11M-0445 |
| Notice date | Jun 15, 2011 |
| Establishment registration | 3014909464 |
| FEI number | 3014909464 |
At a glance
- 10–99 Supplements
- Dec 7, 2023 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- No Withdrawn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: