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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.
 
DeviceCGMS IPRO SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
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/material
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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