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U.S. Department of Health and Human Services

Premarket Approval - PMA
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PMA
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elecsys free psa ROCHE DIAGNOSTICS CORP. P000027S039 02/08/2024
aurora ev icd Medtronic, Inc. P220012S006 11/29/2023
open pivot heart valve MEDTRONIC ATS MEDICAL, INC. P990046S069 11/07/2023
emblem™ s-icd, BOSTON SCIENTIFIC CORPORATION P110042S185 07/06/2023
adapta, versa, sensia ipg, relia ipg MEDTRONIC Inc. P980035S733 11/18/2022
zenith dissection endovascular system WILLIAM COOK EUROPE APS P180001S002 03/31/2021
gore viatorr tips endoprosthesis W. L. GORE & ASSOCIATES, INC. P040027S073 05/13/2019
innova self-expanding stent system BOSTON SCIENTIFIC CORPORATION P140028S034 12/14/2018
aptima hpv 16 18/45 genotype assay GEN-PROBE INCORPORATED P120007S017 09/28/2018
senza spinal cord stimulation (scs) system Nevro Corporation P130022S014 03/21/2018

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