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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements 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
Date Received12/31/1998
Decision Date09/13/1999
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 99M-4278
Notice Date 10/15/1999
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
This device is indicated for use in the treatment of adult women with stress urinary incontinence (sui) due to intrinsic sphincter deficiency (isd).
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 
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