PMA
P210020: Optilume Urethral Drug Coated Balloon
FDA PMA · Catheter, Balloon, Urethral, Drug-Coated · Urotronic, Inc.
Key facts
| PMA number | P210020 |
|---|---|
| Trade name | Optilume Urethral Drug Coated Balloon |
| Generic name | Catheter, Balloon, Urethral, Drug-Coated |
| Applicant | Urotronic, Inc. |
| Owner/operator | Urotronic Inc |
| Product code | QRH |
| Approval date | Dec 3, 2021 |
| Docket number | 21M-1284 |
| Notice date | Dec 9, 2021 |
| Establishment registration | 3015228875 |
| FEI number | 3015228875 |
At a glance
- 10–99 Supplements
- Jun 23, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: