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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 38 Results
productcode DSQ PMA Number p Decision Date From 1/1/2021 Decision Date To 1/1/2022
 
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PMA
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heartmate 3™ left ventricular assist system Abbott Medical P160054 S041 12/20/2021
heartmate ii left ventricular assist system Abbott Medical P060040 S081 11/24/2021
heartmate 3™ left ventricular assist system Abbott Medical P160054 S040 11/24/2021
heartware® ventricular assist system or heartware®... Medtronic P100047 S191 11/23/2021
heartware ventricular assist system Medtronic P100047 S183 11/22/2021
excor® pediatric ventricular assist device Berlin Heart Inc. P160035 S023 11/18/2021
excor® pediatric ventricular assist device Berlin Heart Inc. P160035 S022 11/02/2021
centrimag circulatory support system Abbott P170038 S008 10/22/2021
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S021 10/20/2021
heartware® ventricular assist system Medtronic P100047 S190 10/18/2021
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