Aortic Coarctation
Vietnam·Risk Class TTBYT Loại D·Covered CP Stent·NUMED, INC.·Registered Nov 02, 2024- Analysis ID
- 2403048ĐKLH/BYT-HTTB
- Submission ID
- 19011026/ĐKLH-BYT-TB-CT
- Product Type
- Covered CP Stent
- Product Code
- CVRDCP8Z16, CVRDCP8Z22, CVRDCP8Z28, CVRDCP8Z34,CVRDCP8Z39, CVRDCP8Z45, CVRDCP8Z50, CVRDCP8Z55, CVRDCP8Z60, CVRDCP10Z39, CVRDCP10Z45, CVRDCP10Z50, CVRDCP10Z55, CVRDCP10Z60.
- Manufacturer
- NUMED, INC.
- Manufacturer Country
- UNITED STATES
- Product Owner
- NUMED, INC.
- Authorized Representative
- CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC
- Intended Use
- * CoA Stenosis: Indicated for implantation at the initial CoA stenosis site or at the site of restenosis in patients with the following clinical symptoms: - Significant surgical stenosis of the aorta, as determined by non-invasive cardiovascular imaging techniques such as echocardiography, MRI, or CT; - Aortic stenosis leading to hemodynamic changes, such as increased left ventricular end-diastolic pressure, systemic hypertension, or impaired left ventricular function; - Aortic stenosis at a location where the percutaneous transluminal angioplasty (PTA) procedure is ineffective or contraindicated; - A stenosis of less than 20% of the diameter of the surrounding blood vessel. Aortic stenosis can increase the risk of vascular damage or flow disruption, or lead to aneurysm formation, which may be associated with CoA stenosis. * Right Ventricular Outflow Tract (RVOT): - Indicated for implantation at the site of the connection from the right ventricle to the pulmonary artery (RVOT), which was determined in the pre-procedural angioplasty to prepare for the percutaneous transluminal coronary angioplasty (PTCA) procedure for the replacement of the pulmonary valve.
- Registration Date
- Nov 02, 2024
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Access comprehensive regulatory information for Aortic Coarctation 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 2403048ĐKLH/BYT-HTTB and manufactured by NUMED, INC.. The authorized representative in Vietnam is CÔNG TY TNHH DƯỢC PHẨM VÀ TRANG THIẾT BỊ Y TẾ HOÀNG ĐỨC.
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