Uryx Urethral Bulking Agent

FDA premarket approval P030030 · Agent, Bulking, Injectable for Gastro-Urology Use

PMA numberP030030

Approval

Applicant
C.R. Bard, Inc.
Received
June 23, 2003
Decision date
December 16, 2004 (APWD)
Supplements
4, latest February 16, 2007
Product code
LNM – Agent, Bulking, Injectable For Gastro-Urology Use

Official FDA PMA record

Approval order statement

APPROVAL FOR THE URYX URETHRAL BULKING AGENT (URYX). THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).