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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 NumberS033
Date Received08/18/2008
Decision Date09/24/2008
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 a change to the carelink personal therapymanagement software for diabetes (mmt-7333) the carelink personal therapy managementsoftware for diabetes is a network based software system residing on a computer server platform connected to the internet. The purpose of this system is to take information transmitted from insulin pumps, continuous glucose monitors and glucose meters, and logbook data entered by the patient, and turn it into medtronic carelink therapy management software for diabetes reports. The reports provide information that can be used to identify trends and track daily activities; such as carbohydrates eaten, meal time, insulin delivery, and blood glucose readings. The softwareversion 4. 6 is a revision to implement several feature enhancements, which include a logbookdiary report, removal of roche accu-check 'aviva' and compact plus meters from meterlistings displayed for users located in countries other than u. S. And canada, and consolidation of the help system that serves as instructions for use.