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)
Let's see:May 18: "submitted detailed clinical report... to the...
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