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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 dermal filler, radiesse® (+) jawline

supplement #: S139
Merz North America, Inc. Nov 29, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler

supplement #: S140
Merz North America, Inc. Nov 30, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S141
Merz North America, Inc. Dec 15, 2022 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S142
Merz North America, Inc. Jan 12, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands

supplement #: S143
Merz North America, Inc. Jan 25, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S144
Merz North America, Inc. Sep 25, 2023 labeling change - pas  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S145
Merz North America, Inc. Apr 26, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® jawline

supplement #: S146
Merz North America, Inc. May 04, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S147
Merz North America, Inc. Sep 23, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) lidocaine jawline

supplement #: S148
Merz North America, Inc. Jun 08, 2023 labeling change - indications/instructions/shelf life/tradename  
  We welcome your comments and feedback about Devices@FDA.
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