PMA supplement
P920023 S001: UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS
FDA PMA supplement · Panel Track · Boston Scientific Corp
Key facts
| Original PMA | P920023 |
|---|---|
| Supplement number | S001 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | UROLUME(TM)ENDOURETHRAL WALLSTENT(R) PROSTHESIS |
| Generic name | STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT |
| Applicant | Boston Scientific Corp |
| Product code | MER |
| Received date | May 6, 1996 |
| Decision date | Apr 11, 1997 |
| Docket number | 98M-0050 |
| Notice date | Feb 9, 1998 |
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: