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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 NumberS018
Date Received11/04/2015
Decision Date12/11/2015
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES IN PRODUCT LABELING- UPDATE TO THE POST-MARKET SURVEILLANCE INFORMATION, FURTHER CLARIFICATION REGARDING ADVERSE EVENTS AND INFORMATION REGARDING TREATMENTS TO POSTMARKET SURVEILLANCE SECTION
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