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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMACROPLASTIQUE IMPLANTS
Generic Nameagent, bulking, injectable for gastro-urology use
ApplicantUROPLASTY, LLC
5420 feltl road
minnetonka, MN 55343
PMA NumberP040050
Date Received12/22/2004
Decision Date10/30/2006
Product Code LNM 
Docket Number 06M-0457
Notice Date 11/08/2006
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MACROPLASTIQUE IMPLANTS. THE DEVICE IS INDICATED FOR TRANSURETHRAL INJECTION IN THE TREATMENT OF ADULT WOMEN DIAGNOSED WITH STRESS URINARY INCONTINENCE (SUI) PRIMARILY DUE TO INTRINSIC SPHINCTER DEFICIENCY (ISD).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S007 S008 S010 S011 S012 
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