Sirolimus Eluting Coronary Stent System
- UID
- MFG/MD/2019/000227_dd9e936185c45bb38483da5470752fd4_c3526e0b6e6a5e3f4c8dbed347c611a7
- Device class
- Class D
- Brand name
- Racer PC
- License holder
- Translumina Therapeutics LLP
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Sirolimus Eluting Coronary Stent System used for treatment of: • Symptomatic coronary artery disease due to discrete de novo or restenosis lesion in native coronary artery. • Symptomatic coronary artery disease due to culprit lesion in saphenous vein graft. • Treatment of Coronary lesion in patients undergoing primary or rescue PCI for acute ST segment elevation myocardial infarction (Racer PC) • Treatment of coronary lesion having athero thrombotic appearance in patients with non-ST-elevation acute coronary syndromes (Racer PC)
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000227_dd9e936185c45bb38483da5470752fd4_c3526e0b6e6a5e3f4c8dbed347c611a7. This device is marketed under the brand name Racer PC. The license holder is Translumina Therapeutics LLP, and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.
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