Everolimus-Eluting Coronary Stent Frame
Vietnam·Risk Class TTBYT Loại D·Theo theo phụ lục·Theo theo phụ lục·Registered Sep 26, 2023- Analysis ID
- 2300958ĐKLH/BYT-HTTB
- Submission ID
- 19010694/ĐKLH-BYT-TB-CT
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Theo theo phụ lục
- Manufacturer Country
- Theo theo phụ lục
- Intended Use
- 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.
- Registration Date
- Sep 26, 2023
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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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