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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 NumberS035
Date Received03/20/2018
Decision Date04/18/2018
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  
Manufacturing site change of the contract manufacturer for the Animas 2.0mL cartridge, which is part of the Animas Vibe System.
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