Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000057_dd9e936185c45bb38483da5470752fd4_327c4bd43cea47097337c06b4b80ae93. This device is marketed under the brand name TM under process. The license holder is KAMAL ENCON INDUSTRIES LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.
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Brand Name
TM under process
License Holder
KAMAL ENCON INDUSTRIES LIMITEDDevice Class
Approving Authority
Sub Zonal Baddi
Product Information
Sirolimus Eluting Coronary Stent system (TM under process) is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (TM under process). Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 47 mm in native coronary arteries with a reference vessel diameter of 2.00 to 4.50 mm
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