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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 NumberS038
Date Received12/26/2018
Decision Date03/19/2019
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for design changes to improve drop, vibration, and shock resistance to the Freestyle Libre Pro Reader.
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