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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, radiesse (+) [radiesse with lidocaine]

supplement #: S074
Merz North America, Inc. Dec 11, 2015 labeling change - indications/instructions/shelf life/tradename  
radiesse (+) lidocaine dermal filler

supplement #: S075
Merz North America, Inc. Dec 29, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse low viscosity injectable implant; radiesse (+) lidocaine dermanl filter

supplement #: S076
Merz North America, Inc. May 31, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse, radiesse(+)

supplement #: S077
Merz North America, Inc. Jun 03, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse,radiesse (+) lidocaine dermal filler

supplement #: S078
Merz North America, Inc. Feb 22, 2016 change design/components/specifications/material  
radiesse low viscosity, radiesse (+)

supplement #: S079
Merz North America, Inc. Jun 03, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filler

supplement #: S080
Merz North America, Inc. Apr 12, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S081
Merz North America, Inc. Jan 20, 2016 postapproval study protocol - osb  
radiesse & radiesse (+) lidocaine dermal filler

supplement #: S082
Merz North America, Inc. Jun 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S083
Merz North America, Inc. Jun 23, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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