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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 PUMPS
Generic NameAutomated insulin dosing , threshold suspend
ApplicantMEDTRONIC Inc.
18000 DEVONSHIRE STREET
NORTHRIDGE, CA 91325-1219
PMA NumberP120010
Supplement NumberS065
Date Received03/18/2015
Decision Date04/16/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
TRANSFER OF PURCHASING, RECEIVING, AND INCOMING INSPECTION ACTIVITIES OFCERTAIN EXTERNAL INSULIN PUMP COMPONENTS USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIMEPUMP SERIES AND THE MINIMED 530G SERIES FROM THE MEDTRONIC MINIMED NORTHRIDGE FACILITY TO THE MEDTRONIC PUERTO RICO OPERATIONS COMPANY AND FEDEX/3PL FACILITIES IN PUERTO RICO. THE PARADIGM REAL쳌]TIME FAMILY OF INSULIN PUMPS AND THE MINIMED 530G INSULIN PUMP ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
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