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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 NumberS027
Date Received06/02/2017
Decision Date10/27/2017
Withdrawal Date 06/11/2020
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the manufacturer of two fastener screws and the lead screw used in the pump drive mechanism for the Animas Vibe Insulin pump. The Animas Vibe Insulin pump is a component of the Animas Vibe System.
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