INDICATIONS, SAFETY, AND WARNINGS Mo.Ma Ultra Proximal Cerebral Protection Device
Note: 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. For more information, please call Medtronic at (877) 526-7890. Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.
Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.
Indications for Use: The 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 (USA) law restricts these devices to sale by or on the order of a physician.
Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.
FTSOP113326-16 Rev. 1A