PMA supplement
P920023 S007: UROLUME ENDOPROSTHESIS
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P920023 |
|---|---|
| Supplement number | S007 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | UROLUME ENDOPROSTHESIS |
| Generic name | Stent, urethral, external sphincter, permanent |
| Applicant | Boston Scientific Corp |
| Product code | MXQ |
| Received date | Oct 1, 1998 |
| Decision date | Mar 29, 1999 |
| Docket number | 99M-0870 |
| Notice date | Apr 15, 1999 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: