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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, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline
Generic NameImplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 COURTNEY ROAD
SUITE 10
FRANKSVILLE, WI 53126
PMA NumberP050052
Supplement NumberS136
Date Received04/12/2022
Decision Date09/02/2022
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the implementation of a different blender into the Calcium Hydroxylapatite (CaHA) particle manufacturing process.
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