INDICATIONS, SAFETY, AND WARNINGS RapidCross PTA Balloon Catheter

This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at 800-961-9055. 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 RapidCross™ PTA rapid exchange balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

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

FTSOP113326-63  Rev. 1B