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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: S011 S010 S012  S014 S008 S016 S017 S015 S020 S022 S023 
S025 S026 S027 S028 S030 S031 S032 S033 S035 S036 S037 S038 
S042 S043 S044 S045 S046 S009 S018 S005 S006 S002 S013 S007 
S004 S001 S019 S003 S048 
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