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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(+) Lidocaine Dermal Filler (BBL)
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP090016
Supplement NumberS060
Date Received06/14/2024
Decision Date07/05/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of an alternative, semi-automated process for secondary packaging of Belotero Balance (+) Lidocaine Dermal Filler in the SyringeOneconfiguration.
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