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Everolimus-Eluting Coronary Artery Stent - Vietnam Registration 2403501ĐKLH/BYT-HTTB

Access comprehensive regulatory information for Everolimus-Eluting Coronary Artery Stent 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 2403501ĐKLH/BYT-HTTB and manufactured by Abbott Medical. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN ABBOTT LABORATORIES GMBH TẠI THÀNH PHỐ HÀ NỘI.

This page provides complete technical specifications, regulatory compliance details, 4 companies making similar products including Boston Scientific Limited, Abbott Medical, and 4 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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2403501ĐKLH/BYT-HTTB
Registration Details
Vietnam MOH Registration: 2403501ĐKLH/BYT-HTTB
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Device Details

Everolimus-Eluting Coronary Artery Stent
VN: Khung giá đỡ động mạch vành có phủ thuốc Everolimus
Risk Class TTBYT Loại D

Registration Details

2403501ĐKLH/BYT-HTTB

17001924/ĐKLH-BYT-TB-CT

Theo theo phụ lục

Theo phụ lục

Company Information

Theo theo phụ lục

Abbott Medical

Technical Details

The Everolimus-coated XIENCE Alpine™ coronary stent system is indicated to improve the luminal diameter of the coronary arteries in the following cases: • Patients with symptomatic coronary artery disease (CAD) due to de novo, separate, native coronary artery lesions. • To restore coronary blood flow in patients with acute myocardial infarction (AMI) who present within 12 hours of symptom onset. • To treat patients with concomitant diabetes, acute coronary syndrome (ACS), double vessel disease (two different lesions in the two main coronary arteries), lesions in the smaller coronary arteries; lesions that would result in the retention of branch vessels (lesions of branch vessels with a diameter < 2 mm or severely calcified < 50%); to treat elderly patients (age ≥ 65 years), and to treat both men and women. • To treat patients at high risk of bleeding (High Bleeding Risk, HBR) according to dual antiplatelet therapy (DAPT) for a minimum duration of 28 days. • 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 lesion to be treated must be less than the designated 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

Nov 14, 2024

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