Edwards Lifesciences Sapien 3 Certitude Kit - HSA Registration DE0502946
Access comprehensive regulatory information for Edwards Lifesciences Sapien 3 Certitude Kit in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0502946 and owned by Edwards Lifesciences LLC. The device was registered on March 28, 2019.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
1. The Edwards SAPIEN 3 system is indicated for use in patients with heart disease due to native calcific aortic stenosis at any or all levels of surgical risk for open heart surgery. 2. The Edwards SAPIEN 3 system is indicated for use in patients with symptomatic heart disease due to a failing aortic bioprosthetic valve or a failing mitral surgical bioprosthetic valve (stenosed, insufficient, or combined) who are judged by a heart team to be at high or greater risk for open surgical therapy (i.e., predicted risk of surgical mortality ≥ 8% at 30 days, based on the Society of Thoracic Surgeons (STS) risk score and other clinical co-morbidities unmeasured by the STS risk calculator).