PMA supplement
P210020 S010: Optilume Urethral Drug Coated Balloon Catheter
FDA PMA supplement · Normal 180 Day Track · Urotronic, Inc.
Key facts
| Original PMA | P210020 |
|---|---|
| Supplement number | S010 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Optilume Urethral Drug Coated Balloon Catheter |
| Generic name | Catheter, Balloon, Urethral, Drug-Coated |
| Applicant | Urotronic, Inc. |
| Product code | QRH |
| Received date | Dec 16, 2024 |
| Decision date | Jun 23, 2025 |
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: