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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 BALANCE DERMAL FILLER
Classification Nameimplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
PMA NumberP090016
Supplement NumberS012
Date Received08/11/2014
Decision Date09/10/2014
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of monitoring of rinse water from the cleaning of items used during the manufacture of the belotero balance dermal filler.
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