Muscular Ventricular Septal Defect Occluder (Lotus , Floret ) - India CDSCO Medical Device Registration
Muscular Ventricular Septal Defect Occluder (Lotus , Floret ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_d36e23aedcb087fbd4aaa5c6aeec8a30_3f67605a36d4620cc9d8a4405e840363. This device is marketed under the brand name First Brand. The license holder is Meril Life Sciences 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
First Brand
License Holder
Meril Life Sciences Pvt. Ltd.Device Class
Approving Authority
Central Drug Standards Control Organization, Ahmedabad
Product Information
It is a percutaneous, transcatheter, occlusion device intended of hemodynamically significant muscular ventricular Septal Defects (First Brand)perimembranous and muscular ventricular septal defects (First Brand). Shunts will be considered hemodynamically significant in patients with the evidence of left ventricular and/or left atrial enlargement for body surface area as documented by transthoracic echocardiography
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