FDA Approval Date

FDA Approval Date. The earlier of: (i) the date on which a Project Catheter receives approval for marketing or selling from the United States Food and Drug Administration or any successor agency; (ii) the date on which Spectranetics or anyone on its behalf commences marketing a Project Catheter in the United States; (iii) the date on which Spectranetics or anyone on its behalf completes the first commercial sale of any Project Catheter in the United States; or (iv) the date on which Spectranetics or anyone on its... behalf accomplishes sales of Project Catheters outside the United States for an amount equal to $5 million in the aggregate in the preceding 12-month period View More