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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 48 Results
productcode DSQ PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
 
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Device
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PMA
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heartware hvad system Medtronic P100047 S169 12/21/2020
heartmate 3 left ventricular assist system (hm3 lv... Abbott Medical P160054 S031 12/17/2020
heartware ventricular assist system Medtronic P100047 S159 11/23/2020
heartware left ventricular assist system Medtronic P100047 S163 11/18/2020
heartmate ii left ventricular assist system (lvas) Abbott Medical P060040 S078 10/27/2020
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S018 10/27/2020
excor pediatric ventricular assist device Berlin Heart Inc. P160035 S017 10/23/2020
heartmate 3 left ventricular assist system (hm3 lv... Abbott Medical P160054 S032 10/20/2020
heartware ventricular assist system Medtronic P100047 S172 10/06/2020
heartware ventricular assist system Medtronic P100047 S171 09/30/2020
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