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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 NumberS002
Date Received08/22/2007
Decision Date10/03/2007
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at uroplasty, inc. , minnetonka, minnesota.
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