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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 1/1/2021 Decision Date To 1/1/2022
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PMA
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Masters HP Valved Graft with Gelweave Valsalva™ Te... Abbott Medical P810002 S115 12/09/2021
BILEAFLET-CENTER OPENING CARDIAC VALVE Abbott Medical P810002 S114 10/20/2021
On-X Ascending Aortic Prosthesis On-X Life Technologies, Inc. P000037 S056 10/13/2021
Carbomedics Prosthetic Heart Valve (CPHV) CORCYM S.r.l. P900060 S063 09/09/2021
Masters Mechanical Heart Valve Abbott Medical P810002 S113 08/19/2021
Open Pivot Aortic Valved Graft MEDTRONIC ATS MEDICAL, INC. P990046 S059 07/29/2021
Open Pivot Heart Valves and Open Pivot Aortic Valv... MEDTRONIC ATS MEDICAL, INC. P990046 S058 04/22/2021
Medical Mechanical Heart Valve Abbott Medical P810002 S110 03/17/2021
On-X Prosthetic Heart Valve and On-X Ascending Aor... On-X Life Technologies, Inc. P000037 S057 03/04/2021
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