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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARELINK PERSONAL SOFTWARE
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS033
Date Received08/18/2008
Decision Date09/24/2008
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
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