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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
Classification Nameimplant, dermal, for aesthetic use
ApplicantANIKA THERAPEUTICS, INC.
PMA NumberP050033
Supplement NumberS001
Date Received01/03/2007
Decision Date07/16/2007
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for: 1) an increase n the buffer concentration of the final product from 12 mm to 50 mm sodium phosphate; 2) the introduction of an antioxidant, i. E. , 0. 1% sodium metabisulfite, into the final product; and 3) the introduction of an 0. 5 ml configuration of cosmetic tissue augmentation product (cta).
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