BIOTRONIK Synsiro Pro Sirolimus Eluting Coronary Stent System - HSA Registration DE0508516
Access comprehensive regulatory information for BIOTRONIK Synsiro Pro Sirolimus 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 DE0508516 and owned by Biotronik AG. The device was registered on September 25, 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.
Synsiro Pro stent is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions (length ≤ 40 mm) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm including the following patient and lesion subsets: •Acute Coronary Syndrome (ACS) •ST-Elevation Myocardial Infarction (STEMI) •Diabetes Mellitus (DM) •Complex Lesions (B2/C) •High Bleeding Risk (HBR) •Long Lesions (LL) (e.g. ≥ 20 mm) •Small Vessels (SV) (e.g. ≤ 2.75 mm) •Multi-Vessel Disease (MVD) •Male/Female •Old Patients (e.g. > 65 y).