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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 Pro Flash Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantAbbott Diabetes Care, Inc.
1360 S. Loop Rd.
Alameda, CA 94502
PMA NumberP150021
Supplement NumberS018
Date Received01/16/2018
Decision Date02/15/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Replacement of a verification sensor in the vision system during manufacture of the Sharp Introducer and optimization of the vision system during manufacture of the Sensor component at the firm’s suppliers. The Sharp Introducer and the Sensor are components of the FreeStyle Libre Pro Flash Glucose Monitoring System.
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