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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 Pro Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantAbbott Diabetes Care Inc.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502
PMA NumberP150021
Supplement NumberS009
Date Received05/22/2017
Decision Date06/12/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for adding an alternate supplier of the redox polymer for FreeStyle Libre Pro sensors. The FreeStyle Libre Pro sensors are part of the FreeStyle Libre Pro Flash Glucose Monitoring System.
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