Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 I've been off-list for a couple months. Any word on FDA approval since last November? Thanks, Dave Boyd C+ 12/18/03 Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 10, 2004 Report Share Posted March 10, 2004 There has not been a lot of news. In a conference call to its investors on Dec 9, 2003, Medical stated that they had completed the application for marketing approval of Conserve Plus. My understanding is that the FDA has 180 days to respond. That gives a deadline in early June. The response could be a request for more information, so there is no guarantee of a yes/no by then. Due to previous problems in putting off a decision using the " request for more information " , the FDA is publicly stating that they are working together with the companies before they submit to avoid such delays. I do not know if this application would have to be reviewed by a panel, if so, the next scheduled meeting of the orthopedic devices panel is on June 3, 2004. The agenda will be made public about a month before that. Not sure if that makes the picture any clearer, but that is what seems to be known. - FDA approval? I've been off-list for a couple months. Any word on FDA approval since last November? Thanks, Dave Boyd C+ 12/18/03 Quote Link to comment Share on other sites More sharing options...
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