의료장비 규제 문서 번역 Confirm Rx Insertable Cardiac Monitor SMART Registry 리셉션형 삽입형 심장 모니터 SMART 등록簿 확인

간략 요약

The purpose of the Confirm Rx SMART Registry is to collect real world data to assess the safety and performance of the Confirm Rx Insertable Cardiac Monitor (ICM) and system over a 12 month period. A sub-set of subjects enrolled in the Confirm Rx SMART Registry will meet the Post Market Clinical Follow-Up (PMCF) requirement for CE mark.