Everolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Everolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000042_c87d460d00d3564b32bb8aea8cee3662_b978ce579930f784b652ea8714ede06d. 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
Hestia- Everolimus Eluting Coronary Stent System is indicated for improving myocardial blood flow and luminal diameter in patients with stenotic lesions in coronary arteries but not limited to patients with symptomatic heart disease, stable angina, unstable angina, non-ST elevation MI or documented silent ischemia due to atherosclerotic lesions in native coronary arteries. Hestia- Everolimus Eluting Coronary Stent System is intended for use in treatment of: 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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