INDICATIONS, SAFETY, AND WARNINGS Fortrex PTA Balloon Catheter
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: Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.
Indications for Use: The Fortrex™ 0.035” OTW PTA balloon catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, 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.
FTSOP113326-54 Rev. 1B