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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 NumberS016
Date Received03/09/2016
Decision Date04/06/2016
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the addition of an inspection procedure for the verification of shipments to the sterilization vendor; the addition of instructions into an existing manufacturing procedure to document sealer settings on the record; the addition of instructions into an existing manufacturing procedure to record additional information and verify the total amount of sterile water used; and to revise latex labeling in line with recent FDA guidance.
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