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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOSMETIC TISSUE AUGMENTATION PRODUCT
Generic NameImplant, dermal, for aesthetic use
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP050033
Supplement NumberS001
Date Received01/03/2007
Decision Date07/16/2007
Withdrawal Date04/24/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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