The comments above really touched upon the different types of changes in the monitoring and controlling phase. Within larger companies typically what I have noted is that ECOs are much more common than NDCs or DNCs. With my current position there are quite a bit of ECO’s that come my way through or that I generate post market data or complaints. These changes generally help the product there are some instances where the change can impact 510k submissions and a new 510k needs to be submitted.