PTCA Catheter
- UID
- IMP/MD/2019/000323_a7d36f5934a191ef9b9439fd936fe51d_5d23cd75621fcf6705f95dd0498a16ae
- Device class
- Class D
- Brand name
- VEGA
- Approving authority
- CDSCO
- Product information
- The Vega Catheter is intended for use in the treatment of patients with clinical symptoms of myocardial ischemia related to the pathological condition of one or more coronary arteries. The Vega PTCA catheter is therefore indicated to dilate the diseased segment(VEGA) in a coronary artery or a coronary bypass, to improve myocardial perfusion. The patients should fulfil one or more of the following criteria • Patients must be judged to be acceptable candidates for coronary bypass surgery. • Patients with single vessel atherosclerotic lesion(VEGA), non-calcified, subtotal and accessible to dilatation with guidewire and catheter. • Certain multi-vessel diseased patients may also be candidates for this procedure. • Certain patients, who have undergone previous coronary bypass surgery with recurrence of symptoms and progression of the disease in the coronary artery, or stenosis and closure of the grafts, may also be candidates.
PTCA Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000323_a7d36f5934a191ef9b9439fd936fe51d_5d23cd75621fcf6705f95dd0498a16ae. This device is marketed under the brand name VEGA. The license holder is Envision Scientific Pvt. Ltd. ,Plot C1B-108 Ichchhapore GIDC Industrial Estate, Bhatpore, Sachin-Hazira Road, ,Surat Gujarat ,394510 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.
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