September 27, 2017 / 11:19 AM / a year ago

BRIEF-TSO3 provides an update on regulatory activity

Sept 27 (Reuters) - Tso3 Inc

* TSO3 provides an update on regulatory activity

* TSO3 Inc - ‍Co has received correspondence from us regulators pertaining to its submission for extended claims for Sterizone VP4 sterilizer​

* TSO3 - Regulators asked to clarify some aspects of proposed labeling consistent with reprocessing of specific duodenoscopes using Sterizone VP4 sterilizer​

* TSO3 Inc - ‍Regulators asked for specific testing to be documented pertaining to what they describe as "challenge features" of identified devices​

* TSO3 Inc - ‍Company is preparing a notice for regulators addressing specific questions, as well as outline intended actions for their comment​

* TSO3 Inc - ‍Company's goal is to provide a complete and final response within 180-day limit established by regulators​ Source text for Eikon: Further company coverage:

0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below