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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.
 
DeviceFlash Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantAbbott Diabetes Care Inc.
1360 SOUTH LOOP RD.
ALAMEDA, CA 94502
PMA NumberP150021
Supplement NumberS036
Date Received10/31/2018
Decision Date04/05/2019
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the implementation of individual sensor calibration (ISC) and incorporation of the ISC methodology in the performance monitoring sampling process
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