CDSCO UID IMP/MD/2020/000346_a7d36f5934a191ef9b9439fd936fe51d_21d619429c841593f73b8de0b47b708c

PTCA Catheter

Concept Medical Research Pvt. Ltd. ,Shop No. 4, Ground Floor, Silver Palm 2, Kodampalli Soc, Timaliyawad, Nanpura ,Surat Gujarat ,395001 ,India·Device Class Class D·India CDSCO·Brand: MAYA NC
Registration details
UID
IMP/MD/2020/000346_a7d36f5934a191ef9b9439fd936fe51d_21d619429c841593f73b8de0b47b708c
Device class
Class D
Brand name
MAYA NC
Approving authority
CDSCO
Product information
The indications and contra-indications are defined for sterile catheters. It is advisable to confirm them for the final device. It is intended to dilate a stenotic portion of a native coronary artery or a bypass graft stenosis for the purpose of improving myocardial perfusion and the for post-dilatation of stents (MAYA NC). The patients should fulfill 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(MAYA NC), 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. • Patients who are undergoing a stent implantation with a stent post-dilatation
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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/2020/000346_a7d36f5934a191ef9b9439fd936fe51d_21d619429c841593f73b8de0b47b708c. This device is marketed under the brand name MAYA NC. The license holder is Concept Medical Research Pvt. Ltd. ,Shop No. 4, Ground Floor, Silver Palm 2, Kodampalli Soc, Timaliyawad, Nanpura ,Surat Gujarat ,395001 ,India, and it is classified as Device Class Class D. The approving authority is CDSCO.

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