Everolimus-Eluting Coronary Artery Stent - Vietnam Registration 2301565ĐKLH/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 2301565ĐKLH/BYT-HTTB and manufactured by Boston Scientific Limited.

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including Abbott Medical, Nano Therapeutics Pvt. Ltd., 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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2301565ĐKLH/BYT-HTTB

Registration Details

Vietnam MOH Registration: 2301565ĐKLH/BYT-HTTB

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Device Details

Everolimus-Eluting Coronary Artery Stent

VN: Giá đỡ động mạch vành phủ thuốc Everolimus

Risk Class TTBYT Loại D

Registration Details

Analysis ID

2301565ĐKLH/BYT-HTTB

Submission ID

000.00.04.G18-210304-0014

Product Type

Promus PREMIER™ MONORAIL™ Everolimus-Eluting Platinum Chromium Coronary Stent System

Product Code

H7493925108220; H7493925112220; H7493925116220; H7493925120220; H7493925128250; H7493925132250; H7493925138250; H7493925108270; H7493925112270; H7493925116270; H7493925120270; H7493925124270; H7493925128270; H7493925132270; H7493925120400; H7493925124400; H7493925124220; H7493925128220; H7493925132220; H7493925108250; H7493925138270; H7493925108300; H7493925112300; H7493925116300; H7493925120300; H7493925124300; H7493925128300; H7493925132300; H7493925138300; H7493925108350; H7493925128400; H7493925132400; H7493925112250; H7493925116250; H7493925120250; H7493925124250; H7493925112350; H7493925116350; H7493925120350; H7493925124350; H7493925128350; H7493925132350; H7493925138350; H7493925108400; H7493925112400; H7493925116400; H7493925138400;

Technical Details

Intended Use

The Everolimus-coated vascular stent PROMUS Premier is indicated to improve the diameter of the coronary lumen in symptomatic patients with chronic ischemic heart disease, including patients with acute myocardial infarction and patients with co-morbid diabetes, due to separate initial coronary artery damage. The Everolimus-coated vascular stent PROMUS Premier is also indicated to treat patients with: • Coronary artery branch damage • Coronary artery ostial damage • Unprotected left main coronary artery damage • Total occlusion of the main coronary artery • Restenosis at the site of the stent in coronary artery damage. The length of the treated damage should be less than the theoretical length of the stent (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm and 38 mm) with the standard blood vessel diameter of 2.25 mm - 4.0 mm.