Allied Healthcare Group Seeks 510(k) for Its Heart Tissue Patch
4/9/2013 8:44:20 AM
Allied submits its 510(k) premarket notification application to the FDA for its CardioCel heart tissue device in treatment of heart deformities and malfunctioning valves. Allied Healthcare Group (ASX: AHZ) submitted its 510(k) application for FDA clearance of its CardioCel device, a tissue patch designed to repair heart deformities and malfunctioning valves. The Australian medical device maker has the green-light in Australia for this product and is waiting to hear back about European CE Mark approval. The company is touting recent study data that shows no tissue calcification 4 years after the device is implanted.
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