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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 #: S149
Merz North America, Inc. Jun 28, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant, radiesse hands, radiesse (+) lidocaine, radiesse (+) jawline

supplement #: S150
Merz North America, Inc. Jul 12, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse®(+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S151
Merz North America, Inc. Aug 12, 2024 change design/components/specifications/material  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S152
Merz North America, Inc. Sep 13, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S153
Merz North America, Inc. Sep 20, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® (+) lidocaine, radiesse® hands, radiesse® (+) jawline

supplement #: S154
Merz North America, Inc. Oct 12, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S155
Merz North America, Inc. Dec 07, 2023 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S156
Merz North America, Inc. Feb 27, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine dermal filler, radiesse® (+) jawline

supplement #: S157
Merz North America, Inc. Mar 13, 2024 process change - manufacturer/sterilizer/packager/supplier  
radiesse® injectable implant, radiesse® hands, radiesse® (+) lidocaine, radiesse® (+) jawline

supplement #: S158
Merz North America, Inc. May 02, 2024 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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