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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.
 
DeviceDERMAL FILLER PRODUCT HYDRELLE (ELEVESS)
Generic NameImplant, dermal, for aesthetic use
ApplicantAnika Therapeutics, Inc.
32 Wiggins Ave.
Beford, MA 01730
PMA NumberP050033
Supplement NumberS013
Date Received06/20/2011
Decision Date03/09/2012
Withdrawal Date04/24/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR UPDATES TO THE APPROVED PRODUCT LABEL BASED ON THE RESULTS OF YOUR POST-APPROVAL CLINICAL STUDY.
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