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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 NumberS003
Date Received04/10/2015
Decision Date10/30/2015
Withdrawal Date06/11/2020
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
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR A CHANGE TO THE MANUFACTURING LOCATION AND PROCESS FOR SPRAY PAINT COATING OF THE ANIMAS VIBE INSULIN PUMP OUTER PLASTIC BASE AND COVER. THE ANIMAS VIBE INSULIN PUMP IS A COMPONENT OF THE ANIMAS VIBE SYSTEM.
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