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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.
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable implant for soft tissue augmenttation
PMA NumberP040047
Supplement NumberS037
Date Received10/14/2014
Decision Date11/12/2014
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Relocation of the quality incoming inspection lab, the installation of the qc clean room, and the installation of an automated temperature/ humidity monitoring system.