Guest guest Posted May 4, 2004 Report Share Posted May 4, 2004 The FDA has published the agenda for the June meeting of the Orthopedic and Rehabilitation Devices panel and the Conserve Plus (C+) product is NOT on the agenda for this panel meeting. Separately, Medical had a conference call with investment analysts in which they stated their expected date to begin marketing C+ in the US " late in the second half of 2004 " . They also indicated that they expected the topic would have to be put before a panel (some new products don't go through that level of open review). The next scheduled meeting of the panel is August 12-13. The final proposed meeting dates for the year are Dec 2-3. Incidentally there is an item on the agenda that may be of interest. On June 3rd 1-5pm EDT the committee will discuss and make recommendations on a draft guidance document for clinical performance data requirements for hip joint prostheses. Not sure what they are proposing there, I have sent some emails to some contacts in the industry to see if they know anything about that. Will let you know what I find out. - Quote Link to comment Share on other sites More sharing options...
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