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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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21 to 30 of 33 Results
productcode DSQ PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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Device
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PMA
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heartmate ii® left ventricular assist system Abbott Medical P060040 S086 06/23/2022
heartware ventricular assist system Medtronic P100047 S199 06/24/2022
heartware ventricular assist system Medtronic P100047 S201 06/28/2022
excor® pediatric ventricular assist device Berlin Heart Inc. P160035 S027 08/04/2022
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S028 08/12/2022
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
heartware hvad system Medtronic P100047 S200 09/08/2022
heartware hvad system Medtronic P100047 S196 09/30/2022
heartmate ii™ left ventricular assist system (lvas... Abbott Medical P060040 S087 10/14/2022
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