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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 6 of 6 Results
productcode LWQ PMA Number p Decision Date From 1/1/2020 Decision Date To 1/1/2021
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Device
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PMA
Number
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Decision
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Carbomedics Prosthetic Heart Valve, Carbo-Seal Asc... CORCYM S.r.l. P900060 S061 09/17/2020
SJM Masters Valved Graft with Hemashield graft tec... Abbott Medical P810002 S112 05/26/2020
SJM Masters HP Valved Graft Abbott Medical P810002 S108 05/18/2020
Mechanical Heart Valve Abbott Medical P810002 S111 05/12/2020
Medtronic Open Pivot Heart Valve, Medtronic Open P... MEDTRONIC ATS MEDICAL, INC. P990046 S057 03/24/2020
Open Pivot Heart Valves and Open Pivot Aortic Valv... MEDTRONIC ATS MEDICAL, INC. P990046 S056 03/20/2020
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