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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
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 NumberS015
Date Received07/22/2013
Decision Date08/19/2013
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITION OF A NEW TEXTURE ANALYZER SYSTEM.
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