TSO3 announced it responded to an additional information request from the US Food and Drug Administration.
TSO3 (TSX:TOS) announced it responded to an additional information request from the US Food and Drug Administration.
As quoted in the press release:
This information is in support of the Company’s submission to extend claims of its innovative STERIZONE VP4 Sterilizer to include terminal sterilization of duodenoscopes.
The Company’s response includes a summary of results from tests evaluating the effect of TSO3‘s sterilization process on specific features incorporated in the design of identified scopes, as well as additional labeling targeted at a selected duodenoscope. Lastly, in its response, the Company defined recommended device inspection and use intervals to assist end-users in their instrument surveillance when performing terminal sterilization of duodenoscopes within the STERIZONE System.