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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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Device
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PMA
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freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S017 12/29/2017
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S015 12/22/2017
t:slim g4 insulin pump with dexcom g4 platinum cgm Tandem Diabetes Care, Inc. P140015 S021 12/21/2017
minimed paradigm real-time revel system MEDTRONIC MINIMED P150019 S033 12/21/2017
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S014 12/21/2017
minimed ipro2 cgm system with enlite sensor MEDTRONIC MINIMED P150029 S013 12/21/2017
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S013 12/20/2017
minimed 630g system with enlite sensor MEDTRONIC MINIMED P150019 S032 11/28/2017
ipro2 continuous glucose monitoring (cgm) system w... MEDTRONIC MINIMED P150029 S012 11/28/2017
freestyle libre pro flash glucose monitoring syste... Abbott Diabetes Care Inc. P150021 S008 11/16/2017
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