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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 1/1/2022 Decision Date To 1/1/2023
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Device
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Applicant
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PMA
Number
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Decision
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Open Pivot Heart Valve, Open Pivot Aortic Valved G... MEDTRONIC ATS MEDICAL, INC. P990046 S065 10/21/2022
On- X Prosthetic Heart Valve, Ascending Aortic Pro... On-X Life Technologies, Inc. P000037 S060 08/01/2022
On X Prosthetic Heart Valve Ascending Aortic Proth... On-X Life Technologies, Inc. P000037 S059 03/24/2022
Medtronic Open Pivot Heart Valve, Medtronic Open P... MEDTRONIC ATS MEDICAL, INC. P990046 S063 03/11/2022
Open Pivot Mechanical Valve (OPHV), Open Pivot Aor... MEDTRONIC ATS MEDICAL, INC. P990046 S062 03/10/2022
Open Pivot Heart Valve, Open Pivot Aortic Valved G... MEDTRONIC ATS MEDICAL, INC. P990046 S064 03/10/2022
Carbomedics® Prosthetic Heart Valve, Carbomedics® ... CORCYM S.r.l. P900060 S064 03/07/2022
Medtronic Open Pivot Mechanical Valve (OPHV), Medt... MEDTRONIC ATS MEDICAL, INC. P990046 S060 01/20/2022
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