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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 NameCGMS IPRO SYSTEM
Classification Namesensor, glucose, invasive
Generic Namecontinuous subcutaneous glucose monitoring system
ApplicantMEDTRONIC MINIMED
PMA NumberP980022
Supplement NumberS028
Date Received05/19/2008
Decision Date07/17/2008
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the mmt-7319 solutions software for cgms ipro continuous glucose recorder to download blood glucose meter values, or manual entry of blood glucose values, from the lifescan ultra 2 and lifescan ultralink meters, in addition to the paradigm link, lifescan ultra and freestyle flash meters.
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