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8 I NOTE R NATO O NAL DAI LY IN THE NEWS Heart valve device implanted into patient for RST time Researchers have implanted the RST transcatheter mitral valve replacement device, which could save the

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What is heart valve device?

A heart valve device is a medical device used to treat heart valve disease by replacing or repairing damaged heart valves.

Who is required to file heart valve device?

Manufacturers, importers, and distributors of heart valve devices are required to file with the appropriate regulatory bodies.

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The filing process for heart valve devices typically includes providing information on the device's design, intended use, materials, and safety and efficacy data.

What is the purpose of heart valve device?

The purpose of a heart valve device is to restore normal function to a damaged heart valve and improve overall heart function.

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Information such as device specifications, clinical testing results, adverse events data, and labeling must be reported on heart valve devices.

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