Drug Eluting Stent - India CDSCO Medical Device Registration
Drug Eluting Stent is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_02c065524b5d157cdf1cefa54280210d_f17b31d018d7436f7d71a01be64da74d. This device is marketed under the brand name Onyx TruCor Zotarolimus-Eluting Coronary Stent System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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Brand Name
Onyx TruCor Zotarolimus-Eluting Coronary Stent System
License Holder
India Medtronic Private LimitedDevice Class
Approving Authority
CDSCO
Product Information
The Resolute Onyx stent system is intended for use in patient eligible for percutaneous transluminal coronary angioplasty (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) with a reference vessel diameter of 2.0 mm to to 5.0mm. The Resolute Onyx stent is indicated for the treatment of the following patients and lesion sunsets. • Diabetes mellitus • Multi vessel disease • Acute Coronary Syndrome (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Acute Myocardial Infraction (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Unstable Angina (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Bifuraction lesions • In-Stent Restenosis (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Chronic Total Occlusion (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Total Occlusion (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Left Main (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) • Small Vessel (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) One month of dual antiplatelet therapy (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) in high bleeding risk (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) patients, including patients who are unable to tolerate long-term DAPT
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