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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.
 
DeviceMEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
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.
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