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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
Applicant
MEDTRONIC MINIMED
18000 devonshire street
northridge, CA 91325-1219
PMA NumberP160007
Supplement NumberS040
Date Received01/27/2021
Decision Date02/25/2021
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 Product No
Approval Order Statement 
Approval for an update to product labeling to warn against a new interference by Hydroxyurea to the continuous glucose monitoring (CGM) component of the system.
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