CDSCO UID IMP/MD/2021/000564_a7d36f5934a191ef9b9439fd936fe51d_2cd16a11e3f36908e341af1c3e8678e2
PTCA Catheter
Envision Scientific Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: CYGNUS II
Registration details
- UID
- IMP/MD/2021/000564_a7d36f5934a191ef9b9439fd936fe51d_2cd16a11e3f36908e341af1c3e8678e2
- Device class
- Class D
- Brand name
- CYGNUS II
- License holder
- Envision Scientific Pvt. Ltd.
- Approving authority
- CDSCO
- Product information
- It 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(CYGNUS II) in a coronary artery or a coronary bypass, to improve myocardial perfusion. The patients should fulfill one or more of the following criteria: 1. Patients must be judged to be acceptable candidates for coronary bypass surgery. 2. Patients with single vessel atherosclerotic lesion(CYGNUS II), non-calcified, subtotal and accessible to dilatation with guidewire and catheter. 3. Certain multi-vessel diseased patients may also be candidates for this procedure. 4. 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.
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About this record
PTCA Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000564_a7d36f5934a191ef9b9439fd936fe51d_2cd16a11e3f36908e341af1c3e8678e2. This device is marketed under the brand name CYGNUS II. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO.
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