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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMACROPLASTIQUE IMPLANTS, MPQ-2.5
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantUROPLASTY, LLC
5420 FELTL ROAD
MINNETONKA, MN 55343
PMA NumberP040050
Supplement NumberS010
Date Received10/03/2012
Decision Date12/28/2012
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO QUALIFY AN ALTERNATIVE SILICONE ELASTOMER MATERIAL FOR THE MACROPLASTIQUE SYRINGE STOPPER, AS WELL AS AN ALTERNATIVE SUPPLIER OF THE SYRINGE STOPPER (NUSIL TECHNOLOGY, LLC AT CARPINTERIA, CA.) THERE IS NO CHANGE TO THE INDICATIONS FOR USE OR LABELING OF THE MACROPLASTIQUE DEVICE.
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