PMA supplement
P030030 S005: BARD TEGRESS URETHRAL IMPLANT
FDA PMA supplement · Special (Immediate Track) · C.R. Bard, Inc.
Key facts
| Original PMA | P030030 |
|---|---|
| Supplement number | S005 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | BARD TEGRESS URETHRAL IMPLANT |
| Generic name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
| Applicant | C.R. Bard, Inc. |
| Product code | LNM |
| Received date | Feb 2, 2007 |
| Decision date | Feb 16, 2007 |
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: