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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.
 
DeviceiPro™ 2 CGM System with Enlite™ Glucose Sensor
Generic Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP150029
Supplement NumberS037
Date Received11/17/2021
Decision Date12/17/2021
Product Codes OZO 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 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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