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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

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
radiesse injectable implant

Merz North America, Inc. Dec 22, 2006   Approval Order
Summary of Safety & Effectiveness
Labeling
radiesse

supplement #: S002
Merz North America, Inc. May 02, 2007 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S003
Merz North America, Inc. Jun 05, 2007 process change - manufacturer/sterilizer/packager/supplier  
radiesse, 1.3 cc and 0.3 cc

supplement #: S004
Merz North America, Inc. Apr 21, 2008 change design/components/specifications/material  
radiesse injectable implant

supplement #: S005
Merz North America, Inc. May 01, 2008 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S006
Merz North America, Inc. Jan 25, 2008 change design/components/specifications/material  
radiesse injectable implant

supplement #: S007
Merz North America, Inc. Feb 27, 2008 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S009
Merz North America, Inc. Jul 11, 2008 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S010
Merz North America, Inc. Jul 30, 2008 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S012
Merz North America, Inc. Oct 16, 2008 process change - manufacturer/sterilizer/packager/supplier  
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