Edwards LifeSciences Edwards SAPIEN 3 Ultra System – Edwards Commander Kit - HSA Registration DE0509665
Access comprehensive regulatory information for Edwards LifeSciences Edwards SAPIEN 3 Ultra System – Edwards Commander 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 DE0509665 and owned by Edwards Lifesciences LLC. The device was registered on August 19, 2024.
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.
• The Edwards SAPIEN 3 Ultra transcatheter heart valve 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. • The Edwards SAPIEN 3 Ultra transcatheter heart valve system is indicated for patients with symptomatic heart disease due to failure (stenosed, insufficient or combined) of an aortic transcatheter bioprosthetic or surgical aortic or mitral bioprosthetic valve who are judged by a heart team, including a cardiac surgeon, 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).