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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.
 
DeviceBELOTERO BALANCE
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP090016
Date Received07/23/2009
Decision Date11/14/2011
Product Code LMH 
Docket Number 11M-0832
Notice Date 11/22/2011
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT00876265
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR BELOTERO BALANCE. 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 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 S022 S023 S025 
S026 S027 S028 S030 S031 S032 S033 S034 S035 S036 S037 S038 
S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 
S054 S057 S058 S059 S060 S061 S063 
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