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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCONTIGEN BARD COLLAGEN IMPLANT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Namecollagen implant for urinary incontinence
ApplicantALLERGAN, INC.
PMA NumberP900030
Supplement NumberS009
Date Received06/13/2005
Decision Date09/21/2006
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised directions for use (dfu) that include information from the post-approval study on cohort b.
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