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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 34 Results
productcode DSQ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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PMA
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heartmate 3 left ventricular assist system Abbott Medical P160054 S024 12/30/2019
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S010 12/20/2019
centrimag circulatory support system Abbott P170038 12/06/2019
heartmate ii left ventricular assist system Abbott Medical P060040 S074 11/20/2019
heartmate 3 left ventricular assist system Abbott Medical P160054 S022 11/20/2019
heartware hvad system Medtronic P100047 S131 11/06/2019
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S011 11/03/2019
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S012 11/03/2019
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S009 10/23/2019
heartware hvad system Medtronic P100047 S139 10/21/2019
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