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Indications, Safety, and WarningsNote: Safety information provided is for the United States. Please refer to your region’s instructions for use for specific details.This therapy is not for everyone. Please consult your physician. A prescription is required. Prior to use, refer to the instructions for use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings, and precautions. Important informationPrior to use, refer to the instructions for use supplied with these devices for indications, contraindications, suggested procedure, warnings, and precautions.Indications for useThe Mo.Ma™ Ultra proximal cerebral protection device is indicated as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures involving lesions of the internal carotid artery and/or the carotid bifurcation.The reference diameter of the external carotid artery should be between 3–6 mm and the reference diameter of the common carotid artery should be between 5–13 mm.Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.FTSOP113326-16 Rev. 1A

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