Abbott Medical XIENCE Skypoint Everolimus Eluting Coronary Stent System - HSA Registration DE0508674
Access comprehensive regulatory information for Abbott Medical XIENCE Skypoint Everolimus Eluting Coronary Stent System in the Singapore medical device market through Pure Global AI's free database. This CLASS COM medical device is registered under HSA registration number DE0508674 and owned by Abbott Medical. The device was registered on November 17, 2023.
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.
Indicated for improving coronary artery luminal diameter in the following: • Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions • For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset • For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions, lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches; for the treatment of elderly patients (age ≥ 65), and for treatment of both men and women • For treatment of patients with high bleeding risk under dual anti-platelet therapy as short as 28 days • For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions, coronary artery bifurcation lesions and • Left main coronary artery lesions for lengths up to 38mm