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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 INECTABLE BULKING AGENT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent, bulking, injectable for gastro-urology use
Applicant
CARBON MEDICAL TECHNOLOGIES, INC.
1290 hammond rd.
st. paul, MN 55110-5876
PMA NumberP980053
Supplement NumberS014
Date Received02/19/2013
Decision Date03/21/2013
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
MODIFICATION TO THE FOIL POUCH SEALER, AND THE ADDITION OF TWO ALTERNATE SEALERS, AND TWO NEW LABEL PRINTING SYSTEMS.
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