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BILLING AND CODING GUIDE INDICATION1: The iStent infinite Trabecular MicroBypass System Model iS3 is an implantable device intended to reduce the intraocular pressure (IOP) of the eye. It is indicated

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What is effectiveness and safety of?

Effectiveness and safety refer to the evaluation of a product's performance and its potential risks to users, often assessed through clinical trials and studies.

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Manufacturers and sponsors of medical products, drugs, and devices are typically required to file reports on their effectiveness and safety to regulatory authorities.

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To fill out effectiveness and safety reports, one must gather clinical data, follow regulatory formats, and ensure all relevant information is documented accurately before submission.

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The purpose is to ensure that medical products are both effective in their intended use and safe for consumers, protecting public health.

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Reports must include clinical trial data, adverse event reports, risk assessments, and any other relevant findings related to product performance and safety.

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