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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 NumberS012
Date Received04/07/2016
Decision Date06/30/2016
Withdrawal Date 06/11/2020
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
Approval Order Statement  
Approval for design and material changes to the Force Sensor Flex assembly and Battery Cap O-Ring used in the Animas Vibe pump.
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