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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

supplement #: S034
Merz North America, Inc. May 30, 2012    
radiesse injectable implant

supplement #: S035
Merz North America, Inc. Nov 08, 2012    
radiesse

supplement #: S036
Merz North America, Inc. Sep 25, 2012 labeling change - indications/instructions/shelf life/tradename  
radiesse injectable implant- 1.5cc, 8071m0, radiesse injectable implant-0.8cc, 8069m0, radiesse injectable implant-0.3cc

supplement #: S037
Merz North America, Inc. Oct 17, 2012    
radiesse injectable implant

supplement #: S038
Merz North America, Inc. Feb 22, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S039
Merz North America, Inc. Apr 23, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiessse

supplement #: S040
Merz North America, Inc. May 30, 2013    
radiesse dermal filler

supplement #: S041
Merz North America, Inc. Jul 16, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S042
Merz North America, Inc. Sep 17, 2013 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant for sub-dermal implantation for the correction of moderate to severe facial wrinkles and fo

supplement #: S043
Merz North America, Inc. Sep 16, 2013 process change - manufacturer/sterilizer/packager/supplier  
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