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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 NumberS019
Date Received07/29/2016
Decision Date11/05/2016
Withdrawal Date06/11/2020
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for modifications to the attachment method that secures the disposable housing to the adhesive patch of the sensor pod of Dexcom’s G4 PLATINUM/G5 Mobile sensor component, which required modifications to the disposable housing, implementation of a semi-automated heat staking machine and a change to the inspection method. The sensor is a component of the Animas Vibe System.
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