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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 10 of 13 Results
productcode LWQ PMA Number p Decision Date From 1/1/2016 Decision Date To 1/1/2017
 
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PMA
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MECHANICAL HEART VALVES Abbott Medical P810002 S099 12/15/2016
SJM Master Series Mechanical Heart Valve with Silz... Abbott Medical P810002 S098 12/01/2016
OPEN PIVOT MECHANICAL HEART VALVES AND OPEN PIVOT ... MEDTRONIC ATS MEDICAL, INC. P990046 S048 12/01/2016
ON-X PROSTHETIC HEART VALVE AND ON-X ASCENDING AO... On-X Life Technologies, Inc. P000037 S047 09/28/2016
OPEN PIVOT HEART VALVE & OPEN PIVOT AORTIC VALVED ... MEDTRONIC ATS MEDICAL, INC. P990046 S047 08/04/2016
ON-X PROSTHETIC HEART VALVE and On-X Ascending Aor... On-X Life Technologies, Inc. P000037 S046 07/25/2016
ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA On-X Life Technologies, Inc. P000037 S045 05/31/2016
BILEAFLET-CENTER OPENING CARDIAC VALVE Abbott Medical P810002 S097 04/27/2016
ATS OPEN PIVOT BILEAFLET HEART VALVE MEDTRONIC ATS MEDICAL, INC. P990046 S046 03/10/2016
ATS OPEN PIVOT BILEAFLET HEART VALVE MEDTRONIC ATS MEDICAL, INC. P990046 S045 03/09/2016
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