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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namepump, infusion, insulin, to be used with invasive glucose sensor
PMA NumberP130007
Supplement NumberS002
Date Received03/26/2015
Decision Date06/22/2015
Product Code
OYC[ Registered Establishments with OYC ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for substitution of 4 components (memory, transistor, micro-processing unit, connector) on the printed circuit board (pcb) of the approved animas vibe insulin pump. One of the replacement components (micro-processing unit) requires a modification to the pcb layout.