GREY:TSTIF - Post by User
Comment by
Xwing229on May 16, 2015 9:04am
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Post# 23735752
RE:RE:RE:A Quick Reaction -- FDA Meeting
RE:RE:RE:A Quick Reaction -- FDA MeetingEcho2 and others.
The FDA is in favor of sterilization. Seems great. What's the next steps for TSO3? Filing for extended claims on VP4 to handle these equipments? The problem if I remember all the saga with the 3 cycles approval in the US is that we basically stripped (by blocking it at the software level) the VP4 of the capability to sterilize the long flexible scopes by not allowing it to do that 3rd cycle. The reason I recall why Rumble dumbed down the VP4 was that FDA wasn't able to handle/understand all the chemistry complex interactions between the differents cycles that ultimately lead to the sterilization of scopes.
If we file for these claims again on VP4 to unlock that cycle, don't we come back to the same problem? Or because we already got the first part approved, FDA will be able to focus on the matters and get it this time?
Hope my comment makes some sense..
Thanks