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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 NumberS052
Date Received02/17/2015
Decision Date08/25/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO THE DSCAP AND CASE BOTTOM TO INCLUDE A METRIC THREAD INTERFACE FOR THE PARADIGM REAL-TIME INSULIN PUMPS, PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS MMT-522, 522K, 523, 523K, 722, 722K, 723, 723K), AND MINIMED 530G INSULIN PUMPS (MODEL NUMBERS MMT-551, 751), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THEMINIMED 530G SYSTEM.
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