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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 9 of 9 Results
productcode OZO PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
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Device
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PMA
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MiniMed 530G System MEDTRONIC Inc. P120010 S139 02/25/2021
MiniMed™ 530G System MEDTRONIC Inc. P120010 S140 12/17/2021
MiniMed 630G System with Smart Guard MEDTRONIC MINIMED P150001 S084 01/14/2021
MiniMed 630G System with SmartGuard MEDTRONIC MINIMED P150001 S090 02/25/2021
MiniMed 630G System MEDTRONIC MINIMED P150001 S091 07/07/2021
MiniMed 630G System with SmartGuard Technology MEDTRONIC MINIMED P150001 S092 10/05/2021
MiniMed™ 630G System with SmartGuard™ MEDTRONIC MINIMED P150001 S093 12/17/2021
iPro2 CGM System with Enlite Glucose Sensor MEDTRONIC MINIMED P150029 S036 02/25/2021
iPro™ 2 CGM System with Enlite™ Glucose Sensor MEDTRONIC MINIMED P150029 S037 12/17/2021
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