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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent, bulking, injectable for gastro-urology use
C.R. Bard, Inc.
13183 harland drive
covington, GA 30014-6421
PMA NumberP030030
Date Received06/23/2003
Decision Date12/16/2004
Withdrawal Date 04/06/2007
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 05M-0089
Notice Date 03/09/2005
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
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).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S005