Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_dd9e936185c45bb38483da5470752fd4_9f60ba44c1640461252c753b0e3c12d7. This device is marketed under the brand name Explorer. The license holder is Dolphin Lifescience India LLP, and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
Explorer
License Holder
Dolphin Lifescience India LLPDevice Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease, including patients with acute myocardial infarction (Explorer), due to discrete de novo native coronary artery lesions. The Sirolimus Eluting Coronary Stent System is also intended to be used for treatment of patients presenting with: • Acute coronary syndrome • Unstable angina • Coronary saphenous vein graft lesions • Coronary artery total occlusion lesions • In-stent restenosis in coronary artery lesions
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