General Investor Information EBR Systems, page-324

Sabine, I've come into this discussion at a later stage, and whilst you obviously need to satisfy yourself (and I am not able to refer to specific presentations that the discussion regarding insertion of the WISE device has been already provided by JM - but i don't recall which presentation (s) it was discussed in).
He has indicated that whilst new surgeons to the procedure need to be guided through the process, he indicated that within a couple of supervised emplacements they are well placed to carry out the procedure. And since the initial trials, in aggregate more than 300 emplacements have been successfully completed within the hand-picked number of clinics involved.
As to the duration of FDA time for approval JM has indicated 6 months from final module submission, plus or minus. He added that timeframe is solely determined by FDA (but surely it must be reasonable since the FDA has given Breakthrough status for this unmet heart condition). The benefits of the Breakthrough Designation, not only enables a higher government funding for each patient, but also ensures that the Company and FDA have an iterative communication with relatively quick turnaround on any particular issue that might arise.
As to Lordolean's point on any delay being a minor issue and more important is whether the device will get approval, JM has stated on many many occasions its not a binary decision any more, both safety and efficacy endpoints were achieved during the SOLVE-CRT trial. Its only a matter of timing for approval.