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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 NumberS015
Date Received05/02/2016
Decision Date06/01/2016
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  
Change to transfer the complaint return and investigation operations for the Dexcom G4 Platinum Sensors from the Dexcom facility in San Diego, California, to the Animas facility in West Chester, Pennsylvania. The Dexcom G4 Platinum Sensors are a component of the Animas Vibe System.
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