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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 14 day Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantAbbott Diabetes Care Inc.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502
PMA NumberP150021
Supplement NumberS045
Date Received08/15/2019
Decision Date09/12/2019
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Update to the shipping pallet configuration, removal of the temperature controls from shipping, and extending in-process shelf life of foil-bagged glucose sensor reels. The glucose sensor is a component of the FreeStyle Libre 14-day and FreeStyle Libre Pro Glucose Monitoring System.
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