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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 NumberS042
Date Received10/31/2014
Decision Date01/29/2015
Product Code OZO 
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR USE OF A THICKER DOUBLE-SIDED TAPE ON THE SOF-SENSOR (MODEL MMT-7002, MMT-7003 AND ENLITE SENSOR (MMT-7008) BASE AS WELL AS CHANGE IN THECONVERTER/DISTRIBUTOR OF THE TAPE. THE SOF-SENSOR (MODEL MMT-7002, MMT-7003) IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, AND IPRO2 PROFESSIONAL CGM SYSTEMS AND THE ENLITE GLUCOSE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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