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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.
 
Trade NameCARELINK IPRO THERAPY MANAGEMENT SOFTWARE
Classification Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS124
Date Received09/19/2012
Decision Date11/16/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications to the carelink ipro therapy management software (mmt-7340) from version 1. 4 to version 1. 5a. The carelink ipro therapy management software (mmt-7340) is a component of the ipro2 professional cgm system (mmt-7745).
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