PTCA Dilatation Catheter - India CDSCO Medical Device Registration
PTCA Dilatation Catheter is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000228_202f771d562f6249579206f69258f1df_e2cfee98a0bf688a80d66155589d4c9c. This device is marketed under the brand name Focus np, Abluminus np, Cynosure. The license holder is Envision Scientific Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is Central Drug Standards Control Organization, Ahmedabad.
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Brand Name
Focus np, Abluminus np, Cynosure
License Holder
Envision Scientific Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
The PTCA dilatation catheter is intended for use in treatment of patient with clinical symptoms of myocardial ischemia related to pathological conditions of one or more coronary arteries. The PTCA Dilatation catheter is therefore indicated to dilate the diseased segment(Focus np, Abluminus np, Cynosure) in a coronary artery or a coronary bypass, to improve myocardial perfusion. The PTCA Dilatation catheter is indicated for patients with following criteria: ๏ง Patient must be judged to be acceptable candidate for coronary bypass surgery. ๏ง Patients with single vessel atherosclerotic lesion (Focus np, Abluminus np, Cynosure), nonโcalcified, subtotal and accessible to dilatation with guidewire and catheter. ๏ง Certain multiโvessel diseased patient 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
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