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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceHYDRELLE
Generic NameImplant, dermal, for aesthetic use
ApplicantAnika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730
PMA NumberP050033
Date Received09/02/2005
Decision Date12/20/2006
Withdrawal Date 04/24/2023
Product Code LMH 
Docket Number 06M-0531
Notice Date 12/26/2006
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR THE COSMETIC TISSUE AUGMENTATION PRODUCT. THIS DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S011 S012 
S013 S014 S015 S016 S017 S018 S019 S020 
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