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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.
 
DeviceRADIESSE® Injectable Implant, RADIESSE® Hands
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.Ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP050052
Supplement NumberS178
Date Received04/14/2026
Decision Date05/14/2026
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 ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
installation and qualification of a new microscope in the Quality Laboratory for post-sterilization particle size testing of Radiesse® and Coaptite®
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