True South ,Where have you seen the statement that the ( FDA...

True South ,Where have you seen the statement that the ( FDA have determined that C-Pulse is a non experimental / investigational device and that the underlying questions of safety and effectiveness have been resolved )? see extract below.

The FDA has assigned the C-Pulse System to a Category B3 designation under IDE number G120201. By assigning the C-Pulse System a Category B3 designation, the FDA determined that the C-Pulse System is non-experimental/investigational. A non-experimental/investigational device refers to a device believed to be in Class I or Class II, or a device believed to be in Class III for which the incremental risk is the primary risk in question (that is, underlying questions of safety and effectiveness of that device type have been resolved), or it is known that the device type can be safe and effective because, for example, other manufacturers have obtained FDA approval for that device type.