Everolimus-Eluting Coronary Artery Stent
Vietnam·Risk Class TTBYT Loại D·Promus PREMIER™ MONORAIL™ Everolimus-Eluting Platinum Chromium Coronary Stent System·Boston Scientific Limited·Registered Nov 20, 2023- 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;
- Manufacturer
- Boston Scientific Limited
- Manufacturer Country
- IRELAND
- 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.
- Registration Date
- Nov 20, 2023
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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.
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