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U.S. Department of Health and Human Services

Devices@FDA
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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 S. Loop Rd.
Alameda, CA 94502
PMA NumberP150021
Supplement NumberS056
Date Received02/18/2022
Decision Date03/16/2022
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Addition of a manufacturing site for the manufacture of a sensor electrode material. The sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre 14-Day Flash Glucose Monitoring System.
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