Sirolimus Based Bifurcation Stent System
- UID
- MFG/MD/2020/000228_f27703a59fac83527824a9455e8100d9_0e88d249d7468e39e89301c11b3256a1
- Device class
- Class C
- Brand name
- Nile SIR, Bifur
- License holder
- Envision Scientific Pvt. Ltd.
- Approving authority
- Central Drug Standards Control Organization, Ahmedabad
- Product information
- It is indicated for improving coronary artery luminal diameter, while simultaneously maintaining side branch access in patients with symptomatic ischemic disease due to discrete de novo lesions (Nile SIR, Bifur) in native coronary arteries involving a major branch with a main branch reference vessel diameter of 2.50 to 3.50 mm and with a side branch reference vessel diameter of 2.00 to 3.00 mm
Sirolimus Based Bifurcation Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000228_f27703a59fac83527824a9455e8100d9_0e88d249d7468e39e89301c11b3256a1. This device is marketed under the brand name Nile SIR, Bifur. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class C. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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