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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 14 Results
productcode LWR PMA Number p Decision Date From 1/1/2024 Decision Date To 1/1/2025
 
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PMA
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Avalus Bioprosthesis and Avalus Ultra Bioprosthesi... Medtronic Inc. P170006 S033 04/22/2024
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis Medtronic Inc. P170006 S034 04/22/2024
Hancock Modified Orifice Valved Conduit MEDTRONIC HEART VALVES P790007 S066 04/22/2024
Freestyle Bioprosthesis Medtronic, Inc. P970031 S073 04/22/2024
EDWARDS INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S074 03/25/2024
MITRIS RESILIA Mitral Valve EDWARDS LIFESCIENCES, LLC. P150048 S079 03/01/2024
Edwards INTUITY Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S073 02/13/2024
INSPIRIS™ RESILIA™ Aortic Valve, KONECT RESILIA Ao... EDWARDS LIFESCIENCES, LLC. P150048 S078 02/13/2024
Avalus™ Bioprosthesis, Avalus Ultra™ Bioprosthesis Medtronic Inc. P170006 S032 02/13/2024
Avalus Ultra Bioprosthesis Medtronic Inc. P170006 S025 01/31/2024
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