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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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1 to 4 of 4 Results
productcode LWQ PMA Number p Decision Date From 1/1/2019 Decision Date To 1/1/2020
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Device
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Applicant
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PMA
Number
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Decision
Date
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On-X Aortic Prosthetic Heart Valve Low Dose Warfar... On-X Life Technologies, Inc. P000037 S054 08/15/2019
Carbomedics Prosthetic Heart Valve (CPHV) CORCYM S.r.l. P900060 S060 07/26/2019
St. Jude Medical Masters Mechanical Heart Valve, R... Abbott Medical P810002 S109 03/25/2019
On-X Prosthetic Heart Valve On-X Life Technologies, Inc. P000037 S053 02/26/2019
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