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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 8 of 8 Results
productcode LWQ PMA Number p Decision Date From 1/1/2018 Decision Date To 1/1/2019
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Device
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PMA
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Decision
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SJM Masters HP 15mm Rotatable Mechanical Heart Val... Abbott Medical P810002 S107 12/07/2018
On-X Prosthetic Heart Valve, Model Onxa On-X Life Technologies, Inc. P000037 S052 10/18/2018
Carbomedics Prosthetic Heart Valve (CPHV) CORCYM S.r.l. P900060 S059 08/07/2018
Carbomedics Prosthetic Heart Valve CORCYM S.r.l. P900060 S058 07/11/2018
Open Pivot Mechanical Heart Valve; Open Pivot Aort... MEDTRONIC ATS MEDICAL, INC. P990046 S054 07/11/2018
Carbomedics Prosthetic Heart Valve CORCYM S.r.l. P900060 S057 05/24/2018
SJM Masters Series Mechanical Heart Valve, 15mm HP Abbott Medical P810002 S101 03/06/2018
Mechanical Heart Valves and Vlaved Grafts Abbott Medical P810002 S106 02/27/2018
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