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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 9 of 9 Results
productcode LWQ PMA Number p Decision Date From 1/1/2023 Decision Date To 1/1/2024
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Device
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PMA
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SJM Masters Series Mechanical Heart Valve, 15mm HP Abbott Medical P810002 S119 12/04/2023
On-X Prosthetic Heart Valve and Ascending Aortic P... On-X Life Technologies, Inc. P000037 S061 11/08/2023
Open Pivot heart valve MEDTRONIC ATS MEDICAL, INC. P990046 S069 11/07/2023
SJM™ Masters Series Mechanical Heart Valve, SJM Re... Abbott Medical P810002 S120 10/18/2023
Medtronic Open Pivot Aortic Valved Graft (AVG) MEDTRONIC ATS MEDICAL, INC. P990046 S066 07/19/2023
Masters HP Valved Graft with Gelweave Valsalva™ Te... Abbott Medical P810002 S118 03/31/2023
BILEAFLET-CENTER OPENING CARDIAC VALVE Abbott Medical P810002 S117 03/28/2023
Masters Mechanical Heart Valve, Regent Mechanical ... Abbott Medical P810002 S116 01/27/2023
CARBOMEDICS Prosthetic Heart Valve (CPHV) CORCYM S.r.l. P900060 S062 01/13/2023
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