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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 Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS128
Date Received11/14/2012
Decision Date02/11/2013
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the packaging of a low dropout (ldo)regulator integrated circuit to halogen free and a change of the solder plating to pure tin solder plating for the minilink real-time transmitter (mmt-7703), cgms ipro recorder (mmt- 7709), and ipro2 recorder (mmt-7741) components of the paradigm real-time, paradigm real-time revel, guardian real-time, cgms ipro, and ipro2 professional glucose monitoring systems.