PMA
P030030: URYX URETHRAL BULKING AGENT
FDA PMA · AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE · C.R. Bard, Inc.
Key facts
| PMA number | P030030 |
|---|---|
| Trade name | URYX URETHRAL BULKING AGENT |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | C.R. Bard, Inc. |
| Owner/operator | C. R. Bard, Inc. |
| Product code | LNM |
| Approval date | Dec 16, 2004 |
| Docket number | 05M-0089 |
| Notice date | Mar 9, 2005 |
| Establishment registration | 1018233 |
| FEI number | 1018233 |
At a glance
- 1–9 Supplements
- Feb 16, 2007 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: