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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.
 
DeviceDURASPHERE INJECTABLE BULKING AGENT
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantCarbon Medical Technologies, Inc.
1290 Hammond Rd.
St. Paul, MN 55110
PMA NumberP980053
Supplement NumberS009
Date Received01/06/2005
Decision Date05/25/2005
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 INCLUSION OF THE 5-YEAR POST-MARKET STUDY INFORMATION IN THE DIRECTIONS FOR USE.
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