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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
Applicant
Abbott Diabetes Care Inc.
1360 south loop rd.
alameda, CA 94502
PMA NumberP150021
Supplement NumberS048
Date Received03/20/2020
Decision Date04/13/2020
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Update to the in-process optical setup and image processing for the vision systems that verify three Critical Quality Attributes of the glucose sensor puck. The sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.
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