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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 54 Results
productcode LWR PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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Device
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PMA
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Biocor Heart Valve Abbott Medical P040021 S033 12/26/2017
Trifecta Heart Valve Abbott Medical P100029 S028 12/26/2017
Avalus Bioprosthesis, Model 400 Medtronic Inc. P170006 S005 12/15/2017
Hancock Modified Orifice Valved Conduit MEDTRONIC HEART VALVES P790007 S052 12/13/2017
Freestyle Bioprosthesis Medtronic, Inc. P970031 S058 12/13/2017
EDWARDS INTUITY ELITE Valve System EDWARDS LIFESCIENCES, LLC. P150036 S021 12/08/2017
Edwards Pericardial Aortic Bioprosthesis and Edwar... EDWARDS LIFESCIENCES, LLC. P150048 S010 12/08/2017
RESILIA Aortic Valve EDWARDS LIFESCIENCES, LLC. P150048 S008 11/30/2017
EDWARDS INTUITY ELITE Valve System EDWARDS LIFESCIENCES, LLC. P150036 S020 11/27/2017
Edwards INSPIRIS RESILIA Aortic Valve and Edwards ... EDWARDS LIFESCIENCES, LLC. P150048 S007 11/27/2017
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