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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 dermal filter

supplement #: S106
Merz North America, Inc. Jul 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse hands, radiesse (+) lidocaine dermal filler

supplement #: S108
Merz North America, Inc. Jul 05, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+)

supplement #: S109
Merz North America, Inc. Jul 06, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S110
Merz North America, Inc. May 03, 2019 labeling change - pas  
radiessse hands, and radiesse (+) lidocaine dermal filler

supplement #: S111
Merz North America, Inc. May 17, 2019 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler (1.5cc and 0.8cc)

supplement #: S112
Merz North America, Inc. Jun 06, 2019 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S113
Merz North America, Inc. Jun 07, 2019 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implany and radiesse (+) lidocaine dermal filler

supplement #: S114
Merz North America, Inc. Jun 07, 2019 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant and radiesse (+) lidocaine dermal filler

supplement #: S115
Merz North America, Inc. Nov 06, 2019 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant and radiesse (+) lidocaine dermal filler

supplement #: S116
Merz North America, Inc. Dec 21, 2020 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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