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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 Nameartificial pancreas device system, threshold suspend
PMA NumberP120010
Supplement NumberS042
Date Received10/31/2014
Decision Date01/29/2015
Product Code
OZO[ Registered Establishments with OZO ]
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 use of a thicker double-sided tape on the sof-sensor (model mmt-7002, mmt-7003 and enlite sensor (mmt-7008) base as well as change in the converter/distributor of the tape. The sof-sensor (model mmt-7002, mmt-7003) is a component of the paradigm real-time, paradigm real-time revel, guardian real-time, minilink real-time, and ipro2 professional cgm systems and the enlite glucose sensor (mmt-7008) is a component of the minimed 530g system.