FDA approval requires a minimum of 6 months. More likely 12 to 18 months, if simultaneous application was made with the CE submission. Longer if the FDA submission was made after the CE approval process was started.
If data from european use after CE approval is being submitted to the FDA then not much time has gone by to gather it. We just have to be patient.
FDA approval requires a minimum of 6 months. More likely 12 to...
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