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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 NumberS004
Date Received12/16/2016
Decision Date05/31/2017
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02073058
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to increase the sensor manufacturing capacity, at the manufacturing facility ADC Witney, by implementing a high volume sensor manufacturing line setup. The change included updates to the printed flex circuit processing equipment, qualification of a new ISO 8 cleanroom, implementation of new manufacturing and support equipment, and introduction of a new sampling machine. The sensor is a component of the Freestyle Libre Pro Flash Glucose Monitoring System.
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