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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.
 
DeviceANIMAL VIBE SYSTEM
Generic NameSensor, glucose, invasive
ApplicantANIMAS CORP.
965 CHESTERBROOK BLVD.
WAYNE, PA 19087
PMA NumberP130007
Supplement NumberS008
Date Received08/20/2015
Decision Date11/03/2015
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 REPLACING THE FLASH MEMORY OF THE PRINTED CIRCUIT BOARD ASSEMBLY (PCBA) USED IN THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM, AS WELL AS SUBSEQUENT SOFTWARE CHANGES.
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