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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.
 
DeviceBARD TEGRESS URETHRAL IMPLANT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantC.R. Bard, Inc.
13183 HARLAND DRIVE
COVINGTON, GA 30014-6421
PMA NumberP030030
Supplement NumberS003
Date Received08/29/2005
Decision Date05/23/2006
Withdrawal Date 04/06/2007
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE POSTAPPROVAL STUDY PROTOCOL.
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