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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.
 
Trade NameCONTIGEN (TM) BARD (R) COLLAGEN IMPLANT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Namecollagen implant for urinary incontinence
ApplicantALLERGAN, INC.
PMA NumberP900030
Date Received04/27/1990
Decision Date09/30/1993
Withdrawal Date 10/25/2011
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 
S009 S010 S011 
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