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DEPARTMENT OF HEALTH & HUMAN SERVICES June 23, 2017Public Health Serviced and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002Inspire Medical
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Who needs inspire medical systems?
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Inspire medical systems are typically needed by individuals who suffer from obstructive sleep apnea (OSA) and have not found relief from other treatment options.
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People who experience excessive daytime sleepiness, loud snoring, gasping or choking during sleep, and interrupted breathing may benefit from inspire medical systems.
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Patients with moderate to severe OSA who are unable to use or have not been successful with continuous positive airway pressure (CPAP) therapy may be suitable candidates for inspire medical systems.
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What is inspire medical systems?
Inspire Medical Systems is a medical technology company that specializes in developing innovative solutions for the treatment of obstructive sleep apnea.
Who is required to file inspire medical systems?
Medical device manufacturers, distributors, and importers are required to file inspire medical systems.
How to fill out inspire medical systems?
To fill out inspire medical systems, companies need to provide detailed information about their medical devices, including safety and performance data.
What is the purpose of inspire medical systems?
The purpose of inspire medical systems is to ensure that medical devices on the market meet safety and performance standards.
What information must be reported on inspire medical systems?
Information such as device specifications, clinical data, adverse events, and manufacturing processes must be reported on inspire medical systems.
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