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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.
 
DeviceENLITE GLUCOSE SENSORS
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS068
Date Received05/01/2015
Decision Date07/22/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE SUPPLIER OF HUMAN SERUM ALBUMIN (HSA) SOLUTION USED IN THE MANUFACTURE OF THE ENLITE GLUCOSE SENSOR. ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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