Catheter - India CDSCO Medical Device Registration
Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_5513d03dcf1e33d1e561f487a535dd4f_9e8b65cd0ff84db19b75bfbf8c870548. 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 Prevail Paclitaxel-coated PTCA Balloon Catheter is intended for Percutaneous Transluminal Coronary Angioplasty (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) in the coronary arteries with a vessel diameter from 2.0 mm to 4.0 mm to treat de novo lesions, in-stent restenosis (Onyx TruCor Zotarolimus-Eluting Coronary Stent System), and small vessel disease (Onyx TruCor Zotarolimus-Eluting Coronary Stent System)
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