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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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PMA
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ipro™ 2 cgm system with enlite™ glucose sensor MEDTRONIC MINIMED P150029 S037 12/17/2021
ipro2 cgm system with enlite glucose sensor MEDTRONIC MINIMED P150029 S036 02/25/2021
minimed™ 630g system with smartguard™ MEDTRONIC MINIMED P150001 S093 12/17/2021
minimed 630g system with smartguard technology MEDTRONIC MINIMED P150001 S092 10/05/2021
minimed 630g system MEDTRONIC MINIMED P150001 S091 07/07/2021
minimed 630g system with smartguard MEDTRONIC MINIMED P150001 S090 02/25/2021
minimed 630g system with smart guard MEDTRONIC MINIMED P150001 S084 01/14/2021
minimed™ 530g system MEDTRONIC Inc. P120010 S140 12/17/2021
minimed 530g system MEDTRONIC Inc. P120010 S139 02/25/2021
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