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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 NumberS006
Date Received11/08/2013
Decision Date12/05/2013
Product Code OZO 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01112696
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
PC-BASED MANUFACTURING SOFTWARE UPDATE FROM VERSION 2.2A TO VERSION 2.3A AT THE MEDTRONIC MINIMED, NORTHRIDGE FACILITY, AND UPDATE FROM VERSION 2.0D TO VERSION 2.3A AT THE MPROC, JUNCOS FACILITY FOR THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K, MMT-722, AND MMT-722K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, AND MMT-723K), THE GUARDIAN REAL-TIME MONITOR (MODEL: CSS7100) AND THE MINIMED 530G INSULIN PUMP (MODELS MMT-551 AND MMT-751).
Post-Approval StudyShow Report Schedule and Study Progress
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