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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
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
Applicant
MERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP090016
Date Received07/23/2009
Decision Date11/14/2011
Product Code
LMH[ Registered Establishments with LMH ]
Docket Number 11M-0832
Notice Date 11/22/2011
Advisory Committee General & Plastic Surgery
Clinical Trials NCT00876265
NCT00877279
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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 
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