Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Devices@FDA
  • Print
  • Share
  • E-mail
-
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.
 
 < 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 > 
 
169 supplements returned for P050052

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
radiesse and radiesse(+)

supplement #: S064
Merz North America, Inc. May 06, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse, radiesse (+)

supplement #: S065
Merz North America, Inc. Nov 12, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) 0.8cc, radiesse (+) 1.5cc

supplement #: S066
Merz North America, Inc. Jun 03, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) 1.5cc, radiesse (+) 0.8cc

supplement #: S067
Merz North America, Inc. Jul 06, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse

supplement #: S068
Merz North America, Inc. Jul 24, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse injectable implant

supplement #: S069
Merz North America, Inc. Nov 23, 2015 postapproval study protocol - osb  
radiesse injectable implant

supplement #: S070
Merz North America, Inc. Sep 02, 2015 postapproval study protocol - osb  
radiesse, radiesse (+)

supplement #: S071
Merz North America, Inc. Aug 05, 2015 labeling change - indications/instructions/shelf life/tradename  
radiesse, radiesse(+), radiesse

supplement #: S072
Merz North America, Inc. Oct 01, 2015 process change - manufacturer/sterilizer/packager/supplier  
radiesse (+) 0.8cc, radiesse (+) 1.5cc

supplement #: S073
Merz North America, Inc. May 02, 2016 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
-
-