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U.S. Department of Health and Human Services

Devices@FDA
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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
ApplicantMedtronic, Inc.
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP120010
Supplement NumberS052
Date Received02/17/2015
Decision Date08/25/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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.
Post-Approval StudyShow Report Schedule and Study Progress
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