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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.
 
DeviceFreestyle Libre Pro Flash Glucose Monitoring System
Generic Namesensor, glucose, invasive
Applicant
Abbott Diabetes Care Inc.
1360 south loop rd.
alameda, CA 94502
PMA NumberP150021
Supplement NumberS033
Date Received08/20/2018
Decision Date09/19/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Higher volume preparations of stock solutions used to prepare FreeStyle Libre sensors, and qualification of a new supplier for reagents used for FreeStyle Libre sensor lot release testing as well as increased shelf life for those reagents. The FreeStyle Libre sensor is a component of the FreeStyle Libre and FreeStyle Libre Pro Continuous Glucose Monitoring Systems.
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