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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 NameCOAPTITE INJECTABLE IMPLANT
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable implant for soft tissue augmenttation
ApplicantBIOFORM MEDICAL, INC.
PMA NumberP040047
Supplement NumberS012
Date Received12/08/2008
Decision Date01/07/2009
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 Yes
Approval Order Statement 
Additional mixing system to manufacture larger batches of the device.
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