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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 SYSTEM
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS080
Date Received11/27/2015
Decision Date12/23/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
TRANSFER OF TWO SUB-ASSEMBLY PROCESSES FOR THE PARADIGMREAL쳌 TIME, PARADIGM REAL쳌 TIME REVEL, AND MINIMED 530G INSULIN PUMPS FROM MEDTRONIC MINIMED IN NORTHRIDGE, CA TO MEDTRONIC PUERTO RICO OPERATIONS CO. (MPROC). THE PARADIGM REAL ]TIME AND REAL쳌 TIME REVEL INSULIN PUMPS ARE COMPONENTS OF THE PARADIGMREAL쳌]TIME AND REAL쳌 TIME REVEL SYSTEMS, RESPECTIVELY. THE MINIMED 530G INSULIN PUMP IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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