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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 55110-5876
PMA NumberP980053
Supplement NumberS004
Date Received02/26/2002
Decision Date07/30/2002
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE USE OF GRAPHITE BEAD SUBSTRATE MATERIAL AS AN ALTERNATE TO ZIRCONIUM OXIDE IN THE DEVICE.
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