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. |
|
Device | CARELINK PERSONAL SOFTWARE |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S033 |
Date Received | 08/18/2008 |
Decision Date | 09/24/2008 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-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. |
|
|