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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 52 Results
productcode MDS PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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ipro2 cgm system with enlite sensor MEDTRONIC MINIMED P150029 S005 01/11/2017
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S003 01/12/2017
t:slim g4 insulin pump with dexcom g4 platinum cgm Tandem Diabetes Care, Inc. P140015 S018 01/18/2017
dexcom g5 mobile continuous glucose monitoring sys... DEXCOM, INC. P120005 S058 01/19/2017
paradigm real-time revel system MEDTRONIC MINIMED P150019 S024 01/25/2017
t:slim g4 insulin pump with dexcom g4 platinum cgm Tandem Diabetes Care, Inc. P140015 S019 02/08/2017
t:slim g4 insulin pump with dexcom g4 platinum cgm Tandem Diabetes Care, Inc. P140015 S016 03/06/2017
t:slim g4 insulin pump with dexcom g4 platinum cgm Tandem Diabetes Care, Inc. P140015 S017 03/20/2017
paradigm real-time revel system MEDTRONIC MINIMED P150019 S027 03/27/2017
ipro2 cgm system with enlite sensor MEDTRONIC MINIMED P150029 S006 03/27/2017
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