3 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 WMORecruiting
In 2013 the Boston Scientific VERCISE System has obtained regulatory approval for use in the European Union, CE mark was granted for the treatment of intractable primary and secondary dystonia.The objective of the study is to compile characteristics…
Approved WMORecruiting
To establish the safety and effectiveness of the Edwards SAPIEN 3/ SAPIEN 3 Ultra Transcatheter Heart Valve (THV) in subjects with moderate, calcific aortic stenosis (AS)