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 WMOCompleted
To compare the safety and efficacy of the Tack Endovascular System* in subjects with peripheral artery disease (PAD) to a pre-defined performance goal (PG).
Approved WMOCompleted
The device, the cardiac arrhythmia software, is intended to record, store and analyze the heart rate data collected by a PPG sensor to provide the user with notifications of events that indicate an irregular heart rhythm. The information is not…