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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 NumberS053
Date Received02/23/2021
Decision Date09/01/2021
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a change in the membrane layer polymer of the Libre Sensor. The Libre Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System.
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