2 results
Approved WMOPending
The primary objective is to obtain post-market clinical data according to the requirements of the MEDDEV 2.21/2 in order to fulfil 18 post-market surveillance (PMS) obligations according to Section 3.1 of Annex II, 19 Section 3 of Annex IV, Section…
Approved WMOCompleted
The main objective of this study is to assess the efficacy of the closed loop system over an extended period. Secondary objectives are to assess the safety of the closed loop system; to determine the time that the control algorithm is active; to…