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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 Volume (+) Lidocaine Dermal Filler
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
6501 Six Forks Rd.
Raleigh, NC 27615
PMA NumberP250020
Supplement NumberS002
Date Received05/26/2026
Decision Date06/25/2026
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
qualification of an alternative grade of disodium phosphate (salt) used in preparation of Belotero Volume (+) Lidocaine Dermal Filler
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