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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 NumberS008
Date Received05/02/2011
Decision Date05/27/2011
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a new heat sealing instrument for final package manufacturing.
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