INDICATIONS, SAFETY, AND WARNINGS Pacific Plus 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

The Pacific™ Plus PTA balloon catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries; and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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

Warning: Do not exceed the rated burst pressure.

Caution: Larger models of the Pacific Plus PTA balloon catheter may exhibit slower deflation times, particularly on long catheter shafts.

Potential Adverse Events: Possible adverse events associated with use of the Pacific Plus PTA balloon catheter include, but are not limited to, complications related to puncture such as, but not limited to, local hematoma, infection and hemorrhage; dilatation related complications including, but not limited to, dissection, perforation and restenosis; angiography related complications such as, but not limited to, hypotension, drug/allergic reactions and death.

Caution: Federal (USA) law restricts these devices to sale by or on the order of a physician.
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Test data is on file at Medtronic Inc.
Bench test results may not be indicative of clinical performance.

FTSOP113326-09 Rev. 1A