Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
BOSTON SCIENTIFIC ASIA PACIFIC PTE. LTD.
Class D (contains therapeutic product or medicinal product)
Boston Scientific Corporation
Cardiovascular
The SYNERGY MEGATRON Stent System is intended to improve luminal diameter due to discrete, de novo native coronary artery stenosis in patients with symptomatic ischemic heart disease; including those with acute coronary syndromes (acute myocardial infarction and unstable angina), diabetes mellitus, renal failure or who are at a high risk of bleeding. The SYNERGY MEGATRON Stent System is also indicated for use in the following coronary lesion types: • Bifurcation • Ostial • Unprotected left main • Total occlusion • In-stent restenosis • Saphenous vein graft • Multi-vessel disease The treated lesion length should be less than the nominal stent length with a reference vessel diameter of 3.50 mm - 5.00 mm.
Device System Info:[Sterile Medical Device], Sterile (EtO); Models: Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942708350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942708400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942708450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942708500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942712350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942712400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942712450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942712500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942716350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942716400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942716450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942716500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942720350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942720400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942720450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942720500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942724350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942724400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942724450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942724500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942728350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942728400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942728450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942728500, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942732350, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942732400, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942732450, Boston Scientific SYNERGY MEGATRON™ MONORAIL™ - H7493942732500
2021-07-19