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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceBelotero Volume (+) Lidocaine
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
6501 Six Forks Rd.
Raleigh, NC 27615
PMA NumberP250020
Date Received06/26/2025
Decision Date05/19/2026
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT04886232
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for deep (subcutaneous and/or supraperiosteal) injection to improve volume deficit in the mid-face or to correct mid-face contour deficiencies in adults 22 years or older
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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