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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 NumberS042
Date Received11/17/2021
Decision Date12/17/2021
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.
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