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April 19, 2013, Urgent Medical Device Correction 2955842-4012013-002 Intuitive Surgical da Vinci S, Si and Si-e System User Manuals SUBJECT: Update to the da Vinci S, Si and Si-e System User Manuals
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Intuitive Surgical is a company that develops and manufactures medical robots for minimally invasive surgery. Swissmedic is the Swiss Agency for Therapeutic Products.
Manufacturers or distributors of medical devices in Switzerland are required to file with Swissmedic.
The filing process for intuitive surgical - swissmedic involves providing detailed information about the medical device and its intended use.
The purpose of filing with Swissmedic is to ensure that medical devices meet safety and effectiveness standards before being marketed in Switzerland.
Information such as device specifications, intended use, risk assessment, and clinical data must be reported on intuitive surgical - swissmedic.
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