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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 Nameartificial pancreas device system, threshold suspend
Generic Nameartificail pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS001
Date Received11/06/2013
Decision Date10/02/2015
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for adding duplicate existing manufacturing steps to the preparation of bulk glucose oxidase (gox) performed by the supplier for use in the sponsor¿s enlite sensor (model: mmt-7008) and sof-sensor (models: mmt-7002 and mmt-7003) devices. The enlite sensor is a component of the minimed 530g system. The sof-sensor is a component of the paradigm real-time, paradigm realtime revel, guardian real-time, minilink real-time, ipro recorder and ipro2 professional continuous glucose monitoring systems.