Identity
- Trade Name
- URYX URETHRAL BULKING AGENT FDA PMA
- Generic Name
- AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE FDA PMA
Identifiers
- PMA Number
- P030030 FDA PMA
- FDA Product Code
- LNM FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Gastroenterology, Urology FDA PMA
- FDA Decision
- APWD FDA PMA
The Bard URYX Urethral Bulking Agent is an injectable substance classified as an Agent, Bulking, Injectable for Gastro-Urology Use. It is designed for transurethral injection to treat adult women with stress urinary incontinence caused by intrinsic sphincter deficiency (ISD), providing bulking to support urethral closure.
This device is supplied as a sterile, single-use product and is regulated under an FDA Premarket Approval (PMA). It is intended for use in clinical settings by trained healthcare professionals, with specific lot and batch tracking via registration numbers. Compliance with FDA approval (PMA P030030) ensures adherence to safety and efficacy standards for its designated use.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P030030 | Class III | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA PMA P030030 24 fields · synced Sep 18, 2026