INDICATIONS, SAFETY, AND WARNINGS TurboHawk Peripheral Plaque Excision System

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. 


REFERENCE STATEMENT

Important Information: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Indications for Use: The TurboHawk™ peripheral plaque excision system is intended for use in the atherectomy of the peripheral vasculature. The TurboHawk catheter is NOT intended for use in the coronary, carotid, iliac, or renal vasculature.

The TurboHawk catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions (LX-C only).

Caution: Federal (USA) law restricts this product for sale by or on the order of a physician.

FTSOP113326-66  Rev. 1C