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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 14 Results
productcode MDS PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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PMA
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freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S051 12/16/2020
paradigm real-time revel system MEDTRONIC MINIMED P150019 S062 12/01/2020
ipro2 cgm system with enlite sensor MEDTRONIC MINIMED P150029 S035 12/01/2020
guardian connect system MEDTRONIC MINIMED P160007 S039 12/01/2020
g5 mobile continuous glucose monitoring system DEXCOM, INC. P120005 S087 09/03/2020
guardian connect system MEDTRONIC MINIMED P160007 S037 09/02/2020
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S049 07/30/2020
guardian connect system MEDTRONIC MINIMED P160007 S036 06/25/2020
guardian connect system MEDTRONIC MINIMED P160007 S029 05/20/2020
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S046 05/12/2020
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