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US 20060136051A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2006/0136051 A1 (43) Pub. Date: First et al. (54) COATED MEDICAL DEVICE Jun. 22, 2006 of application No. 10/039,816,
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A coated medical device refers to a medical device that has a protective or therapeutic coating applied to its surface to improve its functionality or performance.
Manufacturers and distributors of coated medical devices are required to file information about their products.
The filing process for coated medical devices typically involves providing detailed information about the device, its coating, manufacturing process, intended use, and any relevant clinical data.
The purpose of coating a medical device is to enhance its biocompatibility, reduce chances of infection, improve drug delivery, or provide other functional benefits.
The information typically reported for coated medical devices includes details about the device, coating materials, manufacturing process, intended use, and any adverse events or side effects.
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