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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 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 NumberS026
Date Received08/20/2018
Decision Date09/19/2018
Product Code PZE 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02082184
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.
Post-Approval StudyShow Report Schedule and Study Progress
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