CDSCO UID MFG/MD/2020/000228_202f771d562f6249579206f69258f1df_e2cfee98a0bf688a80d66155589d4c9c

PTCA Dilatation Catheter

Envision Scientific Pvt. Ltd.·Device Class Class D·India CDSCO·Brand: Focus np, Abluminus np, Cynosure
Registration details
UID
MFG/MD/2020/000228_202f771d562f6249579206f69258f1df_e2cfee98a0bf688a80d66155589d4c9c
Device class
Class D
Brand name
Focus np, Abluminus np, Cynosure
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:  Patient must be judged to be acceptable candidate for coronary bypass surgery.  Patients with single vessel atherosclerotic lesion (Focus np, Abluminus np, Cynosure), non‐calcified, subtotal and accessible to dilatation with guidewire and catheter.  Certain multi‐vessel 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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About this record

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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