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New Device Approval

Picture of the deviceSJM Biocor™ and Biocor™ Supra Valves - P040021

This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.

Product Name: SJM Biocor™ and Biocor™ Supra Valves
Applicant: Saint Jude Medical, Inc.
Address: One Lillehei Plaza, St. Paul, MN 55117
Approval Date: August 5, 2005
Approval Letter: http://www.fda.gov/cdrh/pdf4/p040021a.pdf

What is it? The Biocor™ is a heart valve that consists of a small round device with three cusps (pieces of pig tissue that act like one-way doors), mounted in a covered plastic stent that helps keep the round shape. The Biocor™ helps to keep blood flowing in the proper direction in the heart and throughout the body.

How does it work? At certain times, the cusps/doors open and let blood through, and at other times, the cusps close to hold back the blood.

When is it used? When the valves in your heart do not open and close properly, you begin to become short of breath, dizzy, have chest pains, fatigue, or retain fluids. The doctor can listen to your heart with a stethoscope, or do an ultrasound (a type of moving picture of the valves that is taken using sound waves) to see if it is functioning properly. Valves can be malformed at birth, or become damaged or diseased, or a previous artificial heart valve may begin to malfunction, and these need to be replaced.

What will it accomplish? Once replaced, the clinical symptoms should lessen or go away, and the doctor will hear that the valve is working better, or see that it is working better with an echo (picture of the heart valves).

Additional information: Summary of Safety and Effectiveness and labeling will be available at: http://www.fda.gov/cdrh/pdf4/p040021.html

Other:

Updated September 19, 2005

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