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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode NPT PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
 
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Medtronic Evolut FX+ Transcatheter Aortic Valve, E... Medtronic, Inc. P130021 S161 04/19/2024
Medtronic CoreValve™ Evolut R System Medtronic, Inc. P130021 S160 04/10/2024
Edwards SAPIEN 3™ Transcatheter Heart Valve, Edwar... EDWARDS LIFESCIENCES, LLC. P140031 S171 03/25/2024
Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS Medtronic, Inc. P130021 S155 03/22/2024
Medtronic CoreValve™ Evolut™ R Transcatheter Aorti... Medtronic, Inc. P130021 S159 03/21/2024
Navitor™ Transcatheter Aortic Valve, Navitor™ Load... Abbott Medical P190023 S018 03/21/2024
Medtronic CoreValve™ Evolut™ R Transcatheter Aorti... Medtronic, Inc. P130021 S157 03/08/2024
CoreValve EnVeo R Delivery Catheter System, CoreVa... Medtronic, Inc. P130021 S158 03/08/2024
Edwards SAPIEN 3 Transcatheter Heart Valve (THV), ... EDWARDS LIFESCIENCES, LLC. P140031 S170 02/14/2024
Medtronic CoreValve™ Evolut™ R Transcatheter Aorti... Medtronic, Inc. P130021 S156 02/13/2024
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