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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

supplement #: S044
Merz North America, Inc. Oct 24, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse dermal filler

supplement #: S045
Merz North America, Inc. Mar 07, 2014    
radiesse dermal filler

supplement #: S046
Merz North America, Inc. Nov 27, 2013    
radiesse

supplement #: S047
Merz North America, Inc. Dec 11, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S048
Merz North America, Inc. Dec 20, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S049
Merz North America, Inc. Jun 04, 2015 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling &  Labeling 2
radiesse dermal filler

supplement #: S050
Merz North America, Inc. Feb 27, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse dermal filler

supplement #: S051
Merz North America, Inc. Mar 13, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) lidocaine dermal filter

supplement #: S052
Merz North America, Inc. Jan 30, 2015 change design/components/specifications/material  
radiesse dermal filler

supplement #: S053
Merz North America, Inc. May 07, 2014 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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