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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 NameMACROPLASTIQUE IMPLANTS
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent,bulking,injectable for gastro-urology use
ApplicantUROPLASTY, INC.
PMA NumberP040050
Date Received12/22/2004
Decision Date10/30/2006
Product Code
LNM[ Registered Establishments with LNM ]
Docket Number 06M-0457
Notice Date 11/08/2006
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S007 S008 S010 
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