INDICATIONS, SAFETY, AND WARNINGS Pacific Xtreme 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. 


REFERENCE STATEMENT

Important Information: Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, side effects, suggested procedure, warnings and precautions.

Indications for Use: The Pacific Xtreme™ PTA balloon dilatation catheter in 150 mm, 200 mm, 250 mm and 300 mm balloon length is intended to dilate stenoses in femoral, popliteal and infrapopliteal arteries.

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.

FTSOP113326-17 Rev. 1A