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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCONTIGEN BARD COLLAGEN IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantAllergan, Inc.
71 S. Los Carneros Rd.
Goleta, CA 93111
PMA NumberP900030
Supplement NumberS009
Date Received06/13/2005
Decision Date09/21/2006
Withdrawal Date10/25/2011
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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