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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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169 supplements returned for P050052

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Device Name Company Date Approved Supplement Reason Other Information
radiesse injectable implant, radiesse hands, radiesse® (+) lidocaine, radiesse (+) jawline

supplement #: S159
Merz North America, Inc. May 13, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S160
Merz North America, Inc. May 10, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S161
Merz North America, Inc. Jun 18, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant

supplement #: S162
Merz North America, Inc. Mar 31, 2026 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
radiesse (+) lidocaine dermal filler

supplement #: S163
Merz North America, Inc. Jun 25, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse hands

supplement #: S164
Merz North America, Inc. Jul 10, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant, radiesse hands, radiesse (+) lidocaine, radiesse® (+) jawline

supplement #: S165
Merz North America, Inc. Dec 11, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant; radiesse hands; radiesse (+) lidocaine dermal filler; radiesse (+) jawline

supplement #: S166
Merz North America, Inc. Mar 20, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant; radiesse hands; radiesse (+) lidocaine

supplement #: S167
Merz North America, Inc. Apr 01, 2025 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, jawline indication

supplement #: S168
Merz North America, Inc. Jun 10, 2025 process change - manufacturer/sterilizer/packager/supplier  
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