Boston Scientific ACURATE neo2™ Aortic Valve and Transfemoral Delivery System - HSA Registration DE0509919
Access comprehensive regulatory information for Boston Scientific ACURATE neo2™ Aortic Valve and Transfemoral Delivery System in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0509919 and owned by Boston Scientific Corporation. The device was registered on October 16, 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 ACURATE neo2 Aortic Valve, in combination with the ACURATE neo2 Transfemoral Delivery System, is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a Heart Team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.