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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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Device
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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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