Identity
- Trade Name
- Optilume BPH Catheter System FDA PMA
- Generic Name
- Drug coated prostatic dilation catheter for benign prostatic hyperplasia FDA PMA
Identifiers
- PMA Number
- P220029 FDA PMA
- FDA Product Code
- QXB FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Optilume BPH Catheter System is a drug-coated prostatic dilation catheter designed for the treatment of obstructive urinary symptoms. It is specifically indicated for use in men aged 50 years or older who are diagnosed with Benign Prostatic Hyperplasia (BPH).
This medical device is manufactured by Urotronic, Inc. and has received FDA PMA authorization for its clinical application. It functions as a specialized catheter system to address symptoms associated with prostatic enlargement through its drug-coated dilation mechanism.
Frequently asked questions
What is the Optilume BPH Catheter System used for?
The system is indicated for the treatment of obstructive urinary symptoms in men aged 50 and older who are suffering from Benign Prostatic Hyperplasia (BPH).
How does the Optilume BPH Catheter function?
It functions as a drug-coated prostatic dilation catheter, which is designed to dilate the prostatic urethra to alleviate urinary obstruction caused by BPH.
Is the Optilume BPH Catheter System FDA authorized?
Yes, the device has received FDA PMA authorization, as indicated by the regulatory data provided for the system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Press Releases | Optilume - Urotronic, Optilume BPH Catheter System – P220029 - FDA, FDA approves Optilume BPH System - Urology Times, Two-year long-term follow-up of treatment with the Optilume ..., NCT04131907 | Optilume™ BPH Catheter System in Men With ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class III | Active |
| FDA PMA | United States | FDA_PMA | P220029 | Class III | Active |
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Manufacturer
- Manufacturer
- Urotronic, Inc.
Sources (2)
- FDA PMA P220029 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 17, 2026