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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
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
6501 Six Forks Rd.
Raleigh, NC 27615
PMA NumberP250020
Supplement NumberS001
Date Received05/20/2026
Decision Date06/17/2026
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 areas at the Merz Aesthetic GmbH production site
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