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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 49 Results
productcode MDS PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM S... Tandem Diabetes Care, Inc. P140015 S029 12/19/2019
Paradigm Real-Time Revel System MEDTRONIC MINIMED P150019 S061 12/19/2019
iPro2 CGM System with Enlite Sensor MEDTRONIC MINIMED P150029 S034 12/19/2019
Guardian Connect system MEDTRONIC MINIMED P160007 S030 12/19/2019
Guardian Connect System MEDTRONIC MINIMED P160007 S031 12/19/2019
Guardian Connect System MEDTRONIC MINIMED P160007 S033 12/19/2019
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S047 12/16/2019
Paradigm Real-Time Revel System MEDTRONIC MINIMED P150019 S059 11/22/2019
iPro2 CGM System with Enlite Sensor MEDTRONIC MINIMED P150029 S032 11/22/2019
Guardian Connect System MEDTRONIC MINIMED P160007 S026 11/22/2019
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