PMA
P040050: MACROPLASTIQUE IMPLANTS
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · Uroplasty, LLC
Key facts
| PMA number | P040050 |
|---|---|
| Trade name | MACROPLASTIQUE IMPLANTS |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | Uroplasty, LLC |
| Owner/operator | Uroplasty, LLC |
| Product code | LNM |
| Approval date | Oct 30, 2006 |
| Docket number | 06M-0457 |
| Notice date | Nov 8, 2006 |
| Establishment registration | 3002647932 |
| FEI number | 3002647932 |
At a glance
- 10–99 Supplements
- May 9, 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- No Withdrawn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: