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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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Device
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PMA
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heartmate ii left ventricular assist system (lvas) Abbott Medical P060040 S082 01/12/2022
heartmate ii left ventricular assist system Abbott Medical P060040 S083 01/28/2022
heartmate ii left ventricular assist system Abbott Medical P060040 S085 04/11/2022
heartmate ii® left ventricular assist system Abbott Medical P060040 S086 06/23/2022
heartware ventricular assist system Medtronic P100047 S184 05/18/2022
heartware ventricular assist system Medtronic P100047 S192 03/01/2022
heartware® hvad system Medtronic P100047 S193 03/11/2022
heartware ventricular assist system Medtronic P100047 S194 03/15/2022
heartware ventricular assist (hvad) system Medtronic P100047 S195 03/16/2022
heartware hvad system Medtronic P100047 S196 09/30/2022
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