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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode MDS PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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Device
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Applicant
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PMA
Number
Sort by PMA Number [0-9]
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Decision
Date
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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
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S057 04/28/2022
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S056 03/16/2022
FreeStyle Libre Pro Flash Glucose Monitoring Syste... Abbott Diabetes Care Inc. P150021 S055 03/02/2022
Dexcom G5 Mobile Continuous Glucose Monitoring Sys... DEXCOM, INC. P120005 S088 01/20/2022
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