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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 NumberS039
Date Received10/18/2019
Decision Date05/12/2020
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for 1) introducing an alternate adhesive used in the assembly of the sensor puck; 2) introducing an additional sensor puck assembly manufacturing line at an existing manufacturing site; and 3) introducing a new ISO 8 cleanroom in which the additional assembly line will be located. The sensor puck is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Flash Glucose Monitoring Systems.
Post-Approval StudyShow Report Schedule and Study Progress
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