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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 NumberS011
Date Received08/02/2017
Decision Date08/21/2017
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for removal of the acetaminophen interference statement from all FreeStyle Libre Pro labeling, including the Sensor Insert and User Manual.
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