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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® Intense (+) Lidocaine
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
6501 Six Forks Rd.
Raleigh, NC 27615
PMA NumberP250016
Supplement NumberS002
Date Received07/15/2026
Decision Date07/31/2026
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 a new automated washer at Site Lonay used for cleaning utensils and equipment in Belotero Intense (+) Lidocaine manufacturing
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