Complete and/or total approval will probably require US testing, but I believe the first filing will be sufficient for minimally invasive uses, as well as duct/vessel sealing, which the only difference between existing technology and LTC is that existing technology currently only does 4mm-6mm (I believe) and LTC can do up to 13mm ducts/vessels.
As I said on the LMAO board, IMO, today's PR may have been done PRIOR to the filing, so's prospective buyers have a better gist of the potentials when they go to do their DD.
What the lame sellers of recent weeks fail to realize is that tissue welding is no new technology. LTC only vastly improves upon it, which is why it has so many more applications.
They also don't seem to realize that the filing WILL happen, and when it does, there should be a VERY nice bounce ($2-$3?) on just that alone.
FDA approval will trigger institutional buying, and since LTC has already been used in 7000+ operations, approval is almost a shoe-in, especially given Frank D'Amelio's record with obtaining FDA approvals.