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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
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP090016
Supplement NumberS050
Date Received01/24/2023
Decision Date09/27/2023
Product Code LMH 
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT03777917
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for Belotero Balance(R) (+) for Expanding the Indications to Include Volume Augmentation for the Improvement of the Infraorbital Hollow in Adults Over the Age of 21. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds. The device is also indicated for volume augmentation for the improvement of the infraorbital hollow in adults over the age of 21.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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