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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBELOTERO BALANCE
Generic Nameimplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP090016
Supplement NumberS019
Date Received12/01/2015
Decision Date03/29/2017
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the addition of temperature monitoring devices to trans-Atlantic shipments and changes to the incoming inspection procedure.
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