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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 50 Results
productcode LWR PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
 
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Device
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PMA
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Perceval Sutureless Heart Valve CORCYM Canada Corp. P150011 S017 12/16/2019
Avalus Medtronic Inc. P170006 S016 12/10/2019
Hancock Valved Conduit Modified Orifice MEDTRONIC HEART VALVES P790007 S062 12/10/2019
Freestyle Bioprosthesis Medtronic, Inc. P970031 S067 12/10/2019
Biocor, Biocor Supra, Epic and Epic Supra Heart Va... Abbott Medical P040021 S042 12/04/2019
Trifecta and Trifecta GT Heart Valves Abbott Medical P100029 S042 12/04/2019
Edwards Intuity Valves and Delivery Systems EDWARDS LIFESCIENCES, LLC. P150036 S047 11/26/2019
Edwards Pericardial Aortic Bioprostheses and Edwar... EDWARDS LIFESCIENCES, LLC. P150048 S042 11/26/2019
Edwards Intuity Elite Valve System EDWARDS LIFESCIENCES, LLC. P150036 S045 11/24/2019
Edwards Pericardial Aortic Bioprosthesis, Pericard... EDWARDS LIFESCIENCES, LLC. P150048 S041 11/24/2019
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