I think the common understanding is that Covidien, once they came on board were involved in forwarding additional information to the FDA to clarify labelling issues and perhaps broaden the potential market.

Whatever the reason the FDA quite properly indicated it needed additional time to examine and the new information. Next date is November 4th(thereabouts).

Delay not as significant this time as financing is well in place thus there is no need for additional share offerings or "early market redemptions".

Onward and Upward