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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameBELOTERO BALANCE
Classification Nameimplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 
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