Isnt it typical for the process to include many back and forth Q&A reponses rather than just 1? Also if approval is given based on comparison to predicate devices then would it still be required to have more testing and a longer process in the future for all the parts of the LTC generator/platform that are new or above and beyond these other devices? just wondering bc im looking to join the club again. I missed first run from .05- to .50, and then to 1$ plus, im not trying to fall asleep at the wheel again.
"Regarding FDA, they had to supply a response of how their instruments fared against predicate devices such as the Ligasure Vessel Sealing System and the Gyrus PK system Seal Open Forceps, both of which have 7mm vessel sealing claims. They are trying to get the approval for the LTC generator based on these predicate devices, not as its own platform, which would take longer and need to have more testing. I know that they submitted their favorable response about 3 weeks ago so hopefully we will have a present before the holidays!!!"
