PMA supplement
P920023 S015: UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY
FDA PMA supplement · Normal 180 Day Track · Boston Scientific Corp
Key facts
| Original PMA | P920023 |
|---|---|
| Supplement number | S015 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | UROLUME ENDOURETHRAL PROSTHESIS FOR PROSTATIC OBSTRUCTION SECONDARY TO BENIGN PROSTATIC HYPERTROPHY |
| Generic name | STENT, URETHRAL, BULBOUS, PERMANENT OR SEMI-PERMANENT |
| Applicant | Boston Scientific Corp |
| Product code | MES |
| Received date | Jul 1, 2002 |
| Decision date | Jul 22, 2004 |
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: