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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 NumberS005
Date Received03/30/2017
Decision Date04/26/2017
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  
Update the Applicator Sub-Assembly manufacturing process from a manual to an automated process, and to update the Applicator Sub-Assembly drawing to include three updates to quality attributes for measurement checks to provide an additional control for the automated manufacturing process. The Applicator Sub-Assembly is a component of the Sensor Applicator for the Abbott Diabetes Care FreeStyle Libre Pro Flash Glucose Monitoring System.
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