Everolimus-Eluting Coronary Stent Frame - Vietnam Registration 2300958ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Everolimus-Eluting Coronary Stent Frame in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2300958ĐKLH/BYT-HTTB and manufactured by Theo theo phụ lục.
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Device Details
Registration Details
2300958ĐKLH/BYT-HTTB
19010694/ĐKLH-BYT-TB-CT
Theo theo phụ lục
Theo phụ lục
Technical Details
The Everolimus-coated Stent (XIENCE Sierra) is indicated for the treatment of the following conditions: • Patients with symptomatic coronary artery disease due to de novo, separate native coronary artery lesions. • To restore coronary flow in patients with acute myocardial infarction, present within 12 hours of the onset of symptoms. • To treat patients with concomitant diabetes, acute coronary syndrome, double vessel disease (two different coronary arteries involved), lesions in small coronary arteries; lesions that would require the retention of branch vessels (lesions of branch vessels with a diameter < 2 mm or severely calcified < 50 %); to treat elderly patients (≥ 65 years of age), and to treat both men and women. • To treat patients with in-stent restenosis in coronary artery lesions; chronic total occlusions of the coronary arteries (determined as a coronary artery lesion with a TIMI flow of 0 and lasting more than 3 months); and coronary artery bifurcation lesions. In all cases, the length of the treated lesion must be less than the nominal length of the stent (8 mm, 12 mm, 15 mm, 18 mm, 23 mm, 28 mm, 33 mm, or 38 mm) with a reference vessel diameter ≥ 2.00 mm and ≤ 4.25 mm.
Dates and Status
Sep 26, 2023

