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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 NumberS001
Date Received10/06/2000
Decision Date11/01/2000
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 
ADDITION OF AN ALTERNATE SUBCONTRACTOR TO HEAT-SEAL THE TRAY LID PACKAGE FOR THE DURASPHERE INJECTABLE BULKING AGENT(R) AND AN ALTERNATE SUPPLIER FOR TYVEC 1078B LID FOR USE BY THE ALTERNATE SUBCONTRACTOR.
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