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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 (+) lidocaine dermal filler

supplement #: S084
Merz North America, Inc. Oct 26, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S085
Merz North America, Inc. Jun 27, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse 0.8cc

supplement #: S086
Merz North America, Inc. Jul 26, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse 0.8cc and 1.5cc

supplement #: S087
Merz North America, Inc. Jul 29, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S088
Merz North America, Inc. Jun 13, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S089
Merz North America, Inc. Jan 17, 2017 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S090
Merz North America, Inc. Apr 26, 2017 postapproval study protocol - osb  
radiesse injectable implant (dermal fillers)

supplement #: S091
Merz North America, Inc. Apr 26, 2017 postapproval study protocol - osb  
radiesse lidocaine dermal filler

supplement #: S092
Merz North America, Inc. Jan 02, 2018 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S093
Merz North America, Inc. May 05, 2017 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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