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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 SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
Applicant
MEDTRONIC Inc.
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP120010
Supplement NumberS021
Date Received04/11/2014
Decision Date07/10/2014
Product Code
OZO[ Registered Establishments with 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 TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM.
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