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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 (+) lidocaine derma filler

supplement #: S094
Merz North America, Inc. Jun 27, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine injectable implant

supplement #: S095
Merz North America, Inc. Jun 26, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S096
Merz North America, Inc. Sep 18, 2017 postapproval study protocol - osb  
radiesse (+) lidocaine injectable implant

supplement #: S097
Merz North America, Inc. Aug 29, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse hands, radiesse (+) lidocaine

supplement #: S098
Merz North America, Inc. Mar 28, 2018 location change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S099
Merz North America, Inc. Nov 30, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S100
Merz North America, Inc. Nov 21, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse lidocaine dermal filler

supplement #: S102
Merz North America, Inc. Feb 12, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler 1.5cc

supplement #: S104
Merz North America, Inc. Apr 24, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine 0.8cc and 1.5cc

supplement #: S105
Merz North America, Inc. Aug 12, 2018 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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