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Ann: Positive CE Mark Status Report, page-27

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  1. 706 Posts.
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    Let's see:

    May 18: "submitted detailed clinical report... to the BSI"
    March 19: "The COC has determined there is insufficient clinical benefit... will now send this recommendation to BSI for final determination"
    March 19: "A final determination has not been made"
    Oct 19: "BSI is expected to review the CER to inform a final determination"
    Nov 19: "BSI has closed out all concerns... CE mark approval progresses to the final phase"

    By my count:
    Final determination: 3 times (BSI will make a final determination, BSI has not yet made a final determination, BSI will inform a final determination)
    Final phase: 1 (today)
 
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