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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 NumberS005
Date Received08/13/2026
Decision Date09/10/2026
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  
Approval for requalification of the cleanroom and controlled manufacturing areas at Merz Aesthetics GmbH facility (FEI 3036164410) affecting Belotero Volume (+) Lidocaine Dermal Filler
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