Coronary Stent Delivery System
- UID
- IMP/MD/2020/000472_0fedf497d64c8402c898cbdd916f6b52_7f26aca46bf968eaef9894e024c15233
- Device class
- Class D
- Brand name
- Ultraskin
- License holder
- M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,
- Approving authority
- CDSCO
- Product information
- H-Stent™ Coronary Stent Delivery System is indicated for use in: • Patients eligible for balloon angioplasty with symptomatic ischemic heart disease due to discrete de novo and/or restenotic native coronary artery lesions with reference vessel diameters ranging from 2.5 mm to 4.0 mm, and with target vessel stenosis degree more than 70% , or having evident ischemic symptom and target lesion stenosis degree more than 50%. • Patients with acute occlusion or on the verge of occlusion during percutaneous coronary intervention. • ·Patients with significant residual stenosis after simple balloon dilatation. • ·Patients with acute coronary syndromes
Coronary Stent Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000472_0fedf497d64c8402c898cbdd916f6b52_7f26aca46bf968eaef9894e024c15233. This device is marketed under the brand name Ultraskin. The license holder is M/s LepuCare (India) Vascular Solutions Pvt. Ltd.,, and it is classified as Device Class Class D. The approving authority is CDSCO.
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