Allied submits 510(k) application for heart tissue device

04/10/2013 | MassDevice.com (Boston)

Allied Healthcare Group has filed an application with the FDA for 510(k) clearance for its CardioCel tissue patch. The device, which is used to treat malfunctioning heart valves and cardiac deformities, already has been approved in Australia and is awaiting CE mark approval in Europe.

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MassDevice.com (Boston)

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