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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 14 day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
ApplicantAbbott Diabetes Care, Inc.
1360 S. Loop Dr.
Alameda, CA 94502
PMA NumberP160030
Supplement NumberS042
Date Received04/01/2020
Decision Date05/21/2020
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for a manufacturing site located at Tech Group Europe Limited t/a West, Damastown Close, Damastown Industrial Park, Mulhuddart, Dublin 15, D15 K009 Ireland for sensor kit assembly. The sensor kit is a component of the Freestyle Libre 14 day Flash Glucose Monitoring System.
Post-Approval StudyShow Report Schedule and Study Progress
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