Transcatheter Heart Valve System(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo ;) - India CDSCO Medical Device Registration
Transcatheter Heart Valve System(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo ;) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_f70bb49bae4480d896546380409b4f9e_7462732cec3765138c650aa007dc673d. 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
1. Transcatheter Heart Valve system and accessories are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis and for patients with symptomatic heart disease due to failure (First Brand) of a surgical aortic valve, mitral valve and Tricuspid bioprosthetic. Transcatheter Heart Valve (First Brand) system and accessories are also indicated to treat heart disease due to failure of native Bicuspid aortic and Pulmonic valve for patients who are at risk of open surgical therapy; 2. Transcatheter Heart Valve Delivery System is indicated for implantation of the Transcatheter heart valve by balloon expansion; 3. Balloon Dilatation Catheter is indicated for pre-dilatation of native stenotic cardiac valve prior to the implantation of trans-catheter heart valve; 4. Introducer Set is intended to be inserted in the vasculature to provide a conduit for the insertion of endovascular devices while minimizing blood loss associated with such insertions; 5. Transcatheter Heart Valve Crimping Tool (First Brand) is intended for crimping of Transcatheter Heart Valve for implantation; or 6. Transcatheter Heart Valve Crimping Tool (First Brand) intended for crimping of Transcatheter Heart Valve for implantation;
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