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STATEMENT OF WORK (SOW) Solitaire FR Revascularization DeviceThis contract is for the furnishing of the Solitaire FR Revascularization device for the George E. Wahlen VA Salt Lake City Health Care
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A novel device is used to introduce new or improved medical devices to the market that do not have a legally marketed predicate device.
Manufacturers or developers of medical devices that are considered new and lack an existing predicate within the regulatory framework are required to file a novel device application.
To fill out a novel device application, manufacturers must complete the required forms, provide detailed descriptions of the device, include safety and efficacy data, and submit supporting documents as outlined by the regulatory authority.
The purpose of filing a novel device application is to obtain regulatory approval to market and distribute a new medical device while ensuring that it meets safety and effectiveness standards.
The information required typically includes device description, intended use, manufacturing processes, performance data, clinical data, labeling information, and risk assessments.
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