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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.
 
DeviceANIMAS VIBE SYSTEM
Generic NameSensor, glucose, invasive
ApplicantANIMAS CORP.
965 CHESTERBROOK BLVD.
WAYNE, PA 19087
PMA NumberP130007
Supplement NumberS007
Date Received07/21/2015
Decision Date08/18/2015
Withdrawal Date 06/11/2020
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
Approval Order Statement  
CHANGE TO THE CURRENT BASE ASSEMBLY PROCESS USED FOR THE MANUFACTURE OF THEPUMP BASE OF THE ANIMAS VIBE SYSTEM TO IMPROVE OVERALL MANUFACTURING PROCESS EFFICIENCY. THE PROPOSED CHANGES INCLUDE REMOVAL OF REDUNDANT TEST STEPS, SEPARATION OF COMPLEX ASSEMBLYOPERATIONS INTO SEVERAL DISCRETE STEPS, AND THE ADDITION OF AN IDENTICAL ASSEMBLY STATION.
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