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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 NameCOSMETIC TISSUE AUGMENTATION PRODUCT (CTA)
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS003
Date Received09/06/2007
Decision Date11/19/2007
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to manufacturing equipment and procedures.
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