FDA panel recommends PMA process for CryoLife heart valve

An FDA advisory panel recommends that CryoLife's heart valve, the CryoValve allograft, be subject to its most-stringent pre-market approval protocol.

CryoLife, Food & Drug Administration (FDA)

News Well, 510(k), Pre-Market Approval (PMA), Regulatory/Compliance, Replacement Heart Valves

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