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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 23 Results
productcode OYC PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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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
minimed 630g system with enlite sensor MEDTRONIC MINIMED P150019 S032 11/28/2017
animas vibe system ANIMAS CORP. P130007 S027 10/27/2017
animas vibe system ANIMAS CORP. P130007 S031 10/24/2017
t:slim x2 insulin pump with dexcom g5 mobile cgm Tandem Diabetes Care, Inc. P140015 S020 08/25/2017
animas vibe system ANIMAS CORP. P130007 S029 08/17/2017
paradigm real-time revel system enlite sensor MEDTRONIC MINIMED P150019 S031 08/16/2017
ipro2 continuous glucose monitoring (cgm) system MEDTRONIC MINIMED P980022 S200 08/11/2017
paradigm real time revel system MEDTRONIC MINIMED P150019 S030 06/23/2017
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