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U.S. Department of Health and Human Services

Premarket Approval - PMA
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Device Name
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PMA
Number
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Decision
Date
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freestyle bioprosthesis Medtronic, Inc. P970031S073 04/22/2024
roche cobas dna sample preparation kit Roche Molecular Systems, Inc. P140023S029 04/11/2024
on-x prosthetic heart valve On-X Life Technologies, Inc. P000037S062 03/05/2024
elecsys free psa ROCHE DIAGNOSTICS CORP. P000027S039 02/08/2024
protégé™ gps™ self-expanding peripheral stent system MEDTRONIC VASCULAR INC P060001S038 11/21/2023
emblem™ s-icd, BOSTON SCIENTIFIC CORPORATION P110042S185 07/06/2023
heartmate 3™ left ventricular assist system (lvas) Abbott Medical P160054S036 04/28/2021
capsurefix mri lead Medtronic, Inc P090013S314 03/04/2021
mentor memoryshape breast implants MENTOR WORLDWIDE LLC P060028S032 07/01/2020
cobas cmv ROCHE MOLECULAR SYSTEMS, INC. P160041S028 02/06/2020

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