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Device | URYX URETHRAL BULKING AGENT |
Generic Name | AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE |
Applicant | C.R. Bard, Inc. 13183 HARLAND DRIVE COVINGTON, GA 30014-6421 |
PMA Number | P030030 |
Date Received | 06/23/2003 |
Decision Date | 12/16/2004 |
Withdrawal Date
|
04/06/2007 |
Product Code |
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 Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S005 |