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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 NumberS007
Date Received06/30/2008
Decision Date07/24/2008
Product Code
LNM[ Registered Establishments with LNM ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes in the method used to monitor the sterilization cycle for the coaptite® injectable implant for soft tissue augmentation.
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