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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAnimas Vibe System
Generic NamePump, infusion, insulin, to be used with invasive glucose sensor
ApplicantAnimas Corp.
965 Chesterbrook Blvd.
Wayne, PA 19087
PMA NumberP130007
Supplement NumberS024
Date Received03/24/2017
Decision Date04/21/2017
Withdrawal Date06/11/2020
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Implementation of a pump motor refurbishment process for the Animas Vibe Insulin Pump. The refurbishment activities will be conducted in the same building where current pump manufacturing occurs. The Animas Vibe Pump is a component of the Animas Vibe System with the Dexcom G4 PLATINUM Sensor and Transmitter.
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