Allied Healthcare Group seeks 510(k) for its heart tissue patch

April 8, 2013 by Sony Salzman

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 logo

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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