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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 41 Results
productcode NPT PMA Number p Decision Date From 1/1/2022 Decision Date To 1/1/2023
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portico™ Abbott Medical P190023 S011 12/14/2022
crimper EDWARDS LIFESCIENCES, LLC. P140031 S150 12/12/2022
corevalve enveo r delivery catheter system, coreva... Medtronic, Inc. P130021 S128 12/01/2022
medtronic corevalve evolut fx system Medtronic, Inc. P130021 S129 12/01/2022
medtronic corevalve0153 evolut™ r system, medtroni... Medtronic, Inc. P130021 S127 11/28/2022
edwards sapien 3 ultra transcatheter heart valve EDWARDS LIFESCIENCES, LLC. P140031 S140 11/16/2022
edwards sapien 3 transcatheter heart valve system ... EDWARDS LIFESCIENCES, LLC. P140031 S149 11/16/2022
porticotm transcatheter aortic valve implantation ... Abbott Medical P190023 S010 11/09/2022
medtronic corevalve™ evolut™ r dcs (enveo r dcs), ... Medtronic, Inc. P130021 S123 11/03/2022
medtronic evolut pro delivery catheter system, med... Medtronic, Inc. P130021 S125 11/01/2022