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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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1 to 10 of 11 Results
productcode LWQ PMA Number p Decision Date From 1/1/2017 Decision Date To 1/1/2018
 
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PMA
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On-X Ascending Aortic Prosthesis On-X Life Technologies, Inc. P000037 S051 12/14/2017
Open Pivot Heart Valve / Aortic Valved Graft MEDTRONIC ATS MEDICAL, INC. P990046 S050 12/13/2017
ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA On-X Life Technologies, Inc. P000037 S050 12/05/2017
Laser Angle Measurement Tool for Open and Close Le... MEDTRONIC ATS MEDICAL, INC. P990046 S052 11/18/2017
SJM Masters Series mechanical heart valve, SJM Reg... Abbott Medical P810002 S105 11/16/2017
Open Pivot Heart Valve MEDTRONIC ATS MEDICAL, INC. P990046 S051 10/06/2017
Open Pivot Heart Valve, Open Pivot Aortic Valved G... MEDTRONIC ATS MEDICAL, INC. P990046 S049 08/22/2017
St. Jude Medical Mechanical heart Valves Abbott Medical P810002 S103 08/10/2017
Carbomedics Prosthetic Heart Valve (CPHV). CORCYM S.r.l. P900060 S056 03/03/2017
ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AO... On-X Life Technologies, Inc. P000037 S048 02/07/2017
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