well prodisc hasnt been approved for the public only a letter of aprovable was sent meaning fda had to do mfg and packaging inspections.
tier 1 device approval
is a prefer insurance thing meaning its the way the company wants this device approved,meaning more insurance companys will pick up the device if its done in this fashion.
was how it was explained me.
510k was what they failed for.
next inspection 30 to 90 days and once they pass that inspection device will get fda public appoval 2 weeks after.
i'm waiting my self and r not trying to pop anyones bubble.
chuck