ARTG 458833Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated
ARTG ID: 458833 · Terumo Australia Pty Ltd · Terumo Europe NV · Class III · Started August 07, 2024
Good Name: Terumo Australia Pty Ltd - Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated
- Risk Class
- Class III
- Product Type
- Single Device Product
- ARTG Category
- General
- ARTG ID
- 458833
- Start Date
- August 07, 2024
- Effective Date
- August 07, 2024
- Name
- Terumo Europe NV
- Country
- Belgium
- Address
- Interleuvenlaan 40, Leuven, 3001
Ultimaster Nagomi Sirolimus eluting coronary stent system is intended to improve myocardial blood flow in patients with stenotic or occlusive lesions in coronary arteries. The stent is indicated (but not limited) to treat patients with chronic coronary syndrome, acute coronary syndrome (STEMI, NSTEMI & unstable angina), diabetes mellitus, multivessel disease, bifurcation lesions, patients older than 65 years, male & female, patients with totally occluded lesions, long lesions, lesions residing in small coronary vessels, restenotic lesions including in-stent restenosis, ostial lesions, lesions in left main coronary artery & arterial or venous bypass graft. Suitable for both femoral & radial approach.
Access comprehensive regulatory information for Ultimaster Nagomi Sirolimus eluting coronary stent system - Drug-eluting coronary artery stent, biodegradable-polymer-coated in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is registered under ARTG number 458833 and sponsored by Terumo Australia Pty Ltd, manufactured by Terumo Europe NV in Belgium. The device registration started on August 07, 2024.
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