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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, MPQ-2.5
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameagent,bulking,injectable for gastro-urology use
ApplicantUROPLASTY, INC.
PMA NumberP040050
Supplement NumberS010
Date Received10/03/2012
Decision Date12/28/2012
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
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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