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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 SENSOR
Generic Nameautomated insulin dosing , threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS073
Date Received10/19/2015
Decision Date11/18/2015
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 
TO USE A RECENTLY APPROVED SENSOR BASE COMPONENT ON MPROC (MEDTRONIC PUERTO RICO OPERATION COMPANY) ENLITE SENSORS MANUFACTURING LINE, TO INCREASE THE NUMBER OF COMPONENTS (BASES AND CAPS) TREATED PER PLASMA CLEANING CYCLE AND TO INCREASE POST-PLASMA SHELF LIFE THE THE TREATED COMPONENTS. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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