Lombard Medical Technologies Gets CE Mark, Conditional FDA Approval for Stent Staple
LONDON (Thomson Financial) - Lombard Medical Technologies PLC said it has received continued CE Mark approval for a reconfiguration of its endostapler, EndoRefix, as well as conditional FDA approval for its investigational device exemptions (IDE) application for the product.
CE Mark approval is an integral step towards launching a medical device in the European Union.