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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 13 Results
productcode MDS PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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G5 Mobile Continuous Glucose Monitoring System DEXCOM, INC. P120005 S089 12/21/2021
Paradigm™ Real-Time Revel™ System MEDTRONIC MINIMED P150019 S064 12/17/2021
iPro™ 2 CGM System with Enlite™ Glucose Sensor MEDTRONIC MINIMED P150029 S037 12/17/2021
Guardian™ Connect system MEDTRONIC MINIMED P160007 S042 12/17/2021
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S050 11/19/2021
Guardian Connect System MEDTRONIC MINIMED P160007 S041 10/05/2021
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S054 09/30/2021
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S053 09/01/2021
Paradigm Real-Time Revel System MEDTRONIC MINIMED P150019 S063 02/25/2021
iPro2 CGM System with Enlite Glucose Sensor MEDTRONIC MINIMED P150029 S036 02/25/2021
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