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sojourner

12/14/08 5:22 PM

#24976 RE: bbhuey #24975

bbhuey: My guess is that only two handsets (re duct-and-vessel sealing) and VAD.400 generator were submitted for approval during that round. To recall discussions here some while ago, there was apparent evidence that FDA delay of approval was exacerbated by 1) illness of primary examiner and 2) time needed for development of "generation 3" handsets, i.e., the ones approved. However, anything is possible.