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www.fdanews.com/articles/67728-philips-announces-heartstart-onsite-defibrillator-available-for-otc-sale

PHILIPS ANNOUNCES HEARTSTART ONSITE DEFIBRILLATOR AVAILABLE FOR OTC SALE

January 19, 2005

Philips announced that it will offer the HeartStart OnSite Defibrillator for sale without a prescription.

Philips is the first to market a defibrillator OTC to commercial users, making the HeartStart OnSite Defibrillator more easily available for the implementation of early defibrillation programs in communities, schools and businesses. This move follows on the heels of the FDA's clearance of the Philips HeartStart Home Defibrillator in September 2004.

HeartStart, first introduced with a prescription requirement in November 2002, is designed to deliver clear, calm voice commands, guiding the responder through every step of the defibrillation process. Patented voice coaching for adult and infant/child CPR provides instructions and audio cues for each breath. In addition, HeartStart can be used on infants and small children when equipped with specially designed infant/child pads.