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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDURASPHERE INJECTABLE BULKING AGENT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable bulking agent
ApplicantCARBON MEDICAL TECHNOLOGIES, INC.
PMA NumberP980053
Supplement NumberS008
Date Received12/22/2004
Decision Date09/26/2005
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 the 1 ml syringe used to deploy durasphere injectable bulking agent to be changed from a polycarbonate syringe with the latex-free compound tip to a syringe with a polypropylene silicone tip.
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