ElectroCore gammaCore Sapphire CV, Instructions For Use Manual, Page: 2 / 34

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1. EMERGENCY USE AUTHORIZATION
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FDA has issued an Emergency Use Authorization for the emergency use of the gammaCore Sapphire
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CV for acute use at home or in a healthcare setting to treat adult patients with known or suspected
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COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for
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whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by
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their Healthcare Provider, by using non-invasive vagus nerve stimulation (nVNS) on either side of the
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patient
’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic
.
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gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or
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in a healthcare setting to treat adult patients with known or suspected COVID-19 who are
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experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom
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approved drug therapies are not tolerated or provide insufficient symptom relief as
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assessed by their healthcare provider, by using non-invasive vagus nerve stimulation
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(nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-
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19) pandemic.
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gammaCore Sapphire CV has been authorized for the above emergency use by FDA under
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an Emergency Use Authorization.
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gammaCore Sapphire CV has been authorized only for the duration of the declaration that
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circumstances exist justifying the authorization of the emergency use of medical devices
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under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
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terminated or revoked.
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