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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.
 
DeviceFreestyle Libre 14 day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantABBOTT DIABETES CARE INC.
1360 SOUTH LOOP DR.
ALAMEDA, CA 94502-7000
PMA NumberP160030
Supplement NumberS048
Date Received12/20/2021
Decision Date01/19/2022
Product Code PZE 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the revised protocol for the post-approval study
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