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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 NumberS009
Date Received01/28/2014
Decision Date02/27/2014
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  
CHANGE IN THE INSULIN PUMP CASE ASSEMBLY MANUFACTURING PROCESS AT MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC) TO RECEIVE PUMP CASES DIRECTLY FROM A SUPPLIER WITH A NEW KEYPAD AND OVERLAY. THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM.
Post-Approval StudyShow Report Schedule and Study Progress
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