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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Applicant MEDTRONIC MINIMED productcode MDS
 
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Device
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Applicant
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PMA
Number
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Decision
Date
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Guardian Sensor 3 MEDTRONIC MINIMED P160007 S050 01/05/2024
Guardian Sensor 3 MEDTRONIC MINIMED P160007 S049 01/03/2024
Guardian Sensor 3 MEDTRONIC MINIMED P160007 S043 12/16/2022
Enlite Sensor (MMT-7008) MEDTRONIC MINIMED P150019 S065 04/29/2022
Enlite Sensor (MMT-7008) MEDTRONIC MINIMED P150029 S038 04/29/2022
Guardian Sensor (3) (MMT-7020) MEDTRONIC MINIMED P160007 S044 04/29/2022
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
Guardian Connect System MEDTRONIC MINIMED P160007 S041 10/05/2021
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