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"The FDA is pleased that Guidant Corporation is communicating important safety information to the public regarding their implantable defibrillators," said Dr. Daniel Schultz, FDA Director of the Center for Devices and Radiological Health. "The Agency continues to work with the company on this public health issue and encourages patients to talk with their physicians about their Guidant device. As more information becomes available on the devices impacted (CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF), the FDA will share it quickly with the public."
If you are a physician or a patient who has experienced a problem with any of these defibrillators, please send a report to FDA's MedWatch program and to Guidant. See http://www.fda.gov/medwatch/ for filing information or call 1-800-FDA-1088 (1-800-332-1088).
Additional information about this issue is available to the public by calling 1-866-GUIDANT (1-866-484-3268).
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Guidant Press Release (June 24, 2005)
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