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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 49 Results
productcode NPT PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
 
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Device
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PMA
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Medtronic CoreValve System, Medtronic CoreValve Ev... Medtronic, Inc. P130021 S151 12/23/2023
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic... Abbott Medical P190023 S017 12/18/2023
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S169 12/14/2023
Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwar... EDWARDS LIFESCIENCES, LLC. P140031 S167 12/11/2023
Edwards SAPIEN 3 Transcatheter Heart Valve, Edward... EDWARDS LIFESCIENCES, LLC. P140031 S168 12/06/2023
Edwards Commander Delivery System EDWARDS LIFESCIENCES, LLC. P140031 S166 11/20/2023
CoreValve EnVeo R Delivery Catheter System, CoreVa... Medtronic, Inc. P130021 S150 11/07/2023
PorticoTM, NavitorTM, and Navitor Titan Transcathe... Abbott Medical P190023 S016 11/07/2023
Medtronic CoreValve™ Evolut™ PRO Transcatheter Aor... Medtronic, Inc. P130021 S148 11/01/2023
Medtronic CoreValve™ Evolut™ PRO Transcatheter Aor... Medtronic, Inc. P130021 S149 11/01/2023
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