Bolton Medical TREO Abdominal Stent-Graft System - HSA Registration DE0507196
Access comprehensive regulatory information for Bolton Medical TREO Abdominal Stent-Graft 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 DE0507196 and owned by Bolton Medical Inc.. The device was registered on August 23, 2022.
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 TREO Stent-Graft system is intended for the endovascular treatment of infrarenal abdominal aortic and aorto-iliac aneurysms in patients who have appropriate anatomy as described below: • Adequate iliac or femoral access compatible with the required delivery systems • Suprarenal neck angle of less than 45 degrees, • Infrarenal landing neck length of: - 10 mm or greater with an infrarenal angle of less than 60 degrees and an inside diameter of 17 mm – 32 mm, or - 15 mm or greater with an infrarenal angle between 60 and 75 degrees and an inside diameter of 16 mm-30 mm • Distal iliac landing neck of inside diameter: - 8 mm – 13 mm and a length of at least 10 mm or - >13 mm - 20 mm and a length of at least 15 mm