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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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33 supplements returned for P100014

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Device Name Company Date Approved Supplement Reason Other Information
solesta injectable gel

Palette Life Sciences May 27, 2011   Approval Order
Summary of Safety & Effectiveness
Labeling
solesta injectable gel

supplement #: S002
Palette Life Sciences Aug 10, 2011 process change - manufacturer/sterilizer/packager/supplier  
solesta injectable gel

supplement #: S003
Palette Life Sciences Sep 09, 2011 process change - manufacturer/sterilizer/packager/supplier  
solesta

supplement #: S004
Palette Life Sciences Oct 27, 2011 postapproval study protocol - osb  
solesta

supplement #: S005
Palette Life Sciences Apr 24, 2012 postapproval study protocol - osb  
solesta

supplement #: S006
Palette Life Sciences May 04, 2012 process change - manufacturer/sterilizer/packager/supplier  
solesta

supplement #: S007
Palette Life Sciences Apr 12, 2012    
solesta

supplement #: S008
Palette Life Sciences Dec 19, 2012 process change - manufacturer/sterilizer/packager/supplier  
solesta

supplement #: S009
Palette Life Sciences Jan 14, 2014 labeling change - pas  
solesta

supplement #: S011
Palette Life Sciences Feb 26, 2014 postapproval study protocol - osb  
  We welcome your comments and feedback about Devices@FDA.
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