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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 NumberS012
Date Received09/25/2017
Decision Date03/20/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Flextronics Manufacturing Aguascalientes, Boulevard a Zacatecas Km. 9.5 Jesus Maria, Aguascalientes, Mexico 20900 for final assembly of the Freestyle Libre Pro Reader
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