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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 Ct.ney Rd., 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
Predetermined Change Control Plan AuthorizedNo
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:  S005 S006 S022 S023 S030 S026 S027 S032 S033 S046 S051 
S052 S044 S045 S047 S066 S061 S062 S063 S028 S025 S031 S034 
S035 S057 S058 S059 S067 S065 S018 S019 S014 S003 S004 S013 
S015 S001 S008 S002 S016 S017 S011 S010 S012 S042 S043 S036 
S037 S038 S009 S048 S050 S049 S054 S007 S053 S060 S068 S020 
S064 
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