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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBELOTERO BALENCE DERMAL FILLER
Classification Nameimplant, dermal, for aesthetic use
ApplicantMERZ AESTHETICS, INC.
PMA NumberP090016
Supplement NumberS002
Date Received07/02/2012
Decision Date08/10/2012
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the belotero balance instructions for use to include 27 gauge needles as an option for injection.
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