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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 Dermal Filler, Belotero Balance (+) Lidocaine Dermal Filler
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP090016
Supplement NumberS036
Date Received11/06/2019
Decision Date02/04/2020
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for labeling updates to the package inserts and patient information guides for the Belotero Balance Dermal Filler and Belotero Balance (+) Lidocaine Dermal Filler.
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