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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 NameSensor, glucose, invasive
ApplicantAnimas Corp.
965 Chesterbrook Blvd.
Wayne, PA 19087
PMA NumberP130007
Supplement NumberS001
Date Received01/23/2015
Decision Date04/14/2015
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
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR IMPLEMENTATION OF DEXCOM¿S APPROVED SINGLE-PRINTED WIRING ASSEMBLY (PWA) CONFIGURATION TRANSMITTER INTO THE ANIMAS VIBE SYSTEM AS AN ALTERNATIVE TO THE CURRENT DUAL-PWA DESIGN.
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