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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceCONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantAllergan, Inc.
71 SOUTH LOS CARNEROS ROAD
GOLETA, CA 93111
PMA NumberP900030
Date Received04/27/1990
Decision Date09/30/1993
Withdrawal Date 10/25/2011
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the Contigen™ Bard® Collagen Implant. This device is indicated for use in the treatment of urinary incontinence due to intrinsic sphincter deficiency (poor or non-functioning bladder outlet mechanism) that may be helped by a locally injected bulking agent. Contigen implant therapy is intended only for patients who have shown no improvement in their incontinence for at least 12 months.
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S010 S006 S009 S011 
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