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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-1.0CC, 8005P10, COAPTITE INJECTABLE IMPLANT-1.0CC, 8005P10P
Classification Nameagent, bulking, injectable for gastro-urology use
Generic Nameinjectable implant for soft tissue augmenttation
ApplicantMERZ AESTHETICS, INC.
PMA NumberP040047
Supplement NumberS024
Date Received09/20/2012
Decision Date10/18/2012
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 
Addition of defect categories to an existing incoming inspection procedure.
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