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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 13 Results
productcode MDS PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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paradigm™ real-time revel™ system MEDTRONIC MINIMED P150019 S064 12/17/2021
paradigm real-time revel system MEDTRONIC MINIMED P150019 S063 02/25/2021
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
guardian™ connect system MEDTRONIC MINIMED P160007 S042 12/17/2021
guardian connect system MEDTRONIC MINIMED P160007 S035 01/14/2021
guardian connect system MEDTRONIC MINIMED P160007 S040 02/25/2021
guardian connect system MEDTRONIC MINIMED P160007 S041 10/05/2021
g5 mobile continuous glucose monitoring system DEXCOM, INC. P120005 S089 12/21/2021
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S052 01/05/2021
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