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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.
 
DeviceGuardian Connect System
Generic Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Supplement NumberS020
Date Received05/14/2019
Decision Date07/29/2019
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a minor software design change to fix a software anomaly in the Guardian Connect Mobile Application.
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