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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 #: S054
Merz North America, Inc. Jun 19, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse dermal filler

supplement #: S055
Merz North America, Inc. Oct 24, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse 0.8cc, radiesse 1.5cc, radiesse 3.0cc

supplement #: S056
Merz North America, Inc. Aug 20, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse 0.8cc, radiesse 1.5cc, radiesse 3.0 cc

supplement #: S057
Merz North America, Inc. Aug 19, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S058
Merz North America, Inc. Aug 25, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse dermal fillers

supplement #: S059
Merz North America, Inc. Sep 02, 2014 process change - manufacturer/sterilizer/packager/supplier  
radiesse dermal filler

supplement #: S060
Merz North America, Inc. Apr 03, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse, radiesse (+)

supplement #: S061
Merz North America, Inc. Apr 07, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse, radiesse (+), radiesse with lidocaine injectable implant

supplement #: S062
Merz North America, Inc. Oct 28, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse & radiesse (+) dermal filler

supplement #: S063
Merz North America, Inc. Apr 29, 2015 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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