PMA
P220029: Optilume™ BPH Catheter System
FDA PMA · Drug coated prostatic dilation catheter for benign prostatic hyperplasia · Urotronic, Inc.
Key facts
| PMA number | P220029 |
|---|---|
| Trade name | Optilume™ BPH Catheter System |
| Generic name | Drug coated prostatic dilation catheter for benign prostatic hyperplasia |
| Applicant | Urotronic, Inc. |
| Owner/operator | Urotronic Inc |
| Product code | QXB |
| Approval date | Jun 30, 2023 |
| Docket number | 23M-2744 |
| Notice date | Jul 7, 2023 |
| Establishment registration | 3015228875 |
| FEI number | 3015228875 |
At a glance
- 1–9 Supplements
- Dec 15, 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- No Withdrawn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: