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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 NumberS005
Date Received07/06/2015
Decision Date09/24/2015
Withdrawal Date06/11/2020
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE MATERIALS USED IN THE FLEXIBLE COPPER CIRCUIT FOR THE PRINTED CIRCUIT BOARD ASSEMBLY USED WITH THE ANIMAS VIBE INSULIN PUMP, A COMPONENT OF THE ANIMAS VIBE SYSTEM.
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