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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.
 
DeviceMINIMED 530G INSULIN PUMP
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS046
Date Received12/10/2014
Decision Date10/02/2015
Product Code OZO 
Docket Number 15M-4013
Notice Date 11/02/2015
Advisory Committee Clinical Chemistry
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE MINIMED 530G SYSTEM WITH THRESHOLD SUSPEND FEATURING SMARTGUARD TECHNOLOGY. THIS DEVICE IS INDICATED FOR THE FOLLOWING:THE MINIMED 530G SYSTEM IS INTENDED FOR CONTINUOUS DELIVERY OF BASAL INSULIN (AT USER SELECTABLE RATES) AND ADMINISTRATION OF INSULIN BOLUSES (IN USER SELECTABLE AMOUNTS) FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS, SIXTEEN YEARS OF AGE AND OLDER, REQUIRING INSULIN AS WELL AS FOR THE CONTINUOUS MONITORING AND TRENDING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN. THE MINIMED 530G SYSTEM CAN BE PROGRAMMED TO AUTOMATICALLY SUSPEND DELIVERY OF INSULIN WHEN THE SENSOR GLUCOSE VALUE FALLS BELOW A PREDEFINED THRESHOLD VALUE. THE MINIMED 530G SYSTEM CONSISTS OF THE FOLLOWING DEVICES THAT CAN BE USED IN COMBINATION OR INDIVIDUALLY: MINIMED 530G INSULIN PUMP, ENLITE SENSOR, ENLITE SERTER, THE MINILINK REAL-TIME SYSTEM, THE BAYER CONTOUR NEXTLINK GLUCOSE METER, CARELINK PROFESSIONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES, AND CARELINK PERSONAL THERAPY MANAGEMENT SOFTWARE FOR DIABETES. THE SYSTEM REQUIRES A PRESCRIPTION.THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON VALUES PROVIDED BY THE MINIMED 530G SYSTEM. THE MINIMED 530G SYSTEM IS NOT INTENDED TO BE USED DIRECTLY FOR PREVENTING OR TREATING HYPOGLYCEMIA BUT TO SUSPEND INSULIN DELIVERY WHEN THE USER IS UNABLE TO RESPOND TO THETHRESHOLD SUSPEND ALARM TO TAKE MEASURES TO PREVENT OR TREAT HYPOGLYCEMIA HIMSELF. THERAPY TO PREVENT OR TREAT HYPOGLYCEMIA SHOULD BE ADMINISTERED ACCORDING TO THERECOMMENDATIONS OF THE USER¿S HEALTH CARE PROVIDER.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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