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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 EXP
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 NumberS007
Date Received06/29/2004
Decision Date10/27/2004
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR 1 ML SYRINGES WITH SYNTHETIC RUBBER STOPPERS. THESE SYRINGES ARE INTENDED TO STORE DURASPHERE EXP.
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