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 Valvesread more

Source: Mass Device - October 10, 2014 Category: Medical Equipment Authors: Brad Perriello Source Type: news