CDSCO UID IMP/MD/2019/000050_02c065524b5d157cdf1cefa54280210d_f17b31d018d7436f7d71a01be64da74d
Drug Eluting Stent
India Medtronic Private Limited·Device Class Class D·India CDSCO·Brand: Onyx TruCor Zotarolimus-Eluting Coronary Stent System
Registration details
- UID
- IMP/MD/2019/000050_02c065524b5d157cdf1cefa54280210d_f17b31d018d7436f7d71a01be64da74d
- Device class
- Class D
- Brand name
- Onyx TruCor Zotarolimus-Eluting Coronary Stent System
- License holder
- India Medtronic Private Limited
- 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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About this record
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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