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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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30 supplements returned for P130007

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
animas vibe system

Animas Corp. Nov 25, 2014   Approval Order
Summary of Safety & Effectiveness
Labeling
animas vibe system

supplement #: S001
Animas Corp. Apr 14, 2015 change design/components/specifications/material  
animas vibe system

supplement #: S002
Animas Corp. Jun 22, 2015 change design/components/specifications/material  
animas vibe system

supplement #: S003
Animas Corp. Oct 30, 2015 process change - manufacturer/sterilizer/packager/supplier  
animas vibe system

supplement #: S004
Animas Corp. Dec 24, 2015 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
animas vibe system

supplement #: S005
Animas Corp. Sep 24, 2015    
animas vibe system

supplement #: S006
Animas Corp. Aug 10, 2015 process change - manufacturer/sterilizer/packager/supplier  
animas vibe system

supplement #: S007
Animas Corp. Aug 18, 2015 process change - manufacturer/sterilizer/packager/supplier  
animal vibe system

supplement #: S008
Animas Corp. Nov 03, 2015 change design/components/specifications/material  
animas vibe system

supplement #: S009
Animas Corp. Oct 21, 2015 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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