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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 NameMACROPLASTIQUE IMPLANTS
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent,bulking,injectable for gastro-urology use
ApplicantUROPLASTY, INC.
PMA NumberP040050
Supplement NumberS003
Date Received02/18/2009
Decision Date06/26/2009
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling for post approval study
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for labeling modifications to reflect the findings of the enhanced surveillance study.
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