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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 29 Results
productcode DSQ PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
 
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PMA
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centrimag™ circulatory support system Abbott P170038 S010 05/11/2022
centrimag™ circulatory support system Abbott P170038 S009 04/01/2022
heartmate 3™ left ventricular assist system Abbott Medical P160054 S047 04/11/2022
heartmate 3™ left ventricular assist system Abbott Medical P160054 S045 01/28/2022
heartmate 3™ left ventricular assist system (lvas) Abbott Medical P160054 S044 01/12/2022
heartmate 3™ left ventricular assist system Abbott Medical P160054 S043 01/07/2022
heartmate 3™ left ventricular assist system Abbott Medical P160054 S042 02/16/2022
heartmate 3™ left ventricular assist system Abbott Medical P160054 S039 03/24/2022
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S031 08/24/2022
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S030 08/30/2022
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