Transcatheter Heart Valve System - India CDSCO Medical Device Registration
Transcatheter Heart Valve System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_f4e7229724f6eee02862bbd713475a61_2a7c3f85033c8ffd53f30bed6f854995. 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.Myval - Transcatheter Heart Valve: The Myval - Transcatheter Heart Valve (First Brand) system and accessories are Indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis as judged by a heart team (First Brand) and in patients who are at higher risk for open heart surgical therapy (First Brand); 2. Navigator - Transcatheter Heart Valve Delivery System is indicated for delivery of the Transcatheter Heart Valve; 3. Mammoth - Balloon dilatation catheter is indicated for dilatation of native stenotic cardiac valves. It is also indicated for balloon dilatation of the stenotic portion of peripheral vessels and aorta. Further, it is indicated for stenting procedure and pre/post-delivery expansion of stents. 4. Python (First Brand), Python 2 (First Brand), Python Neo (First Brand) - 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. Val-de-Crimp (First Brand), Val-de-Crimp Neo (First Brand), CrocoDial Neo (First Brand) - Transcatheter Heart Valve Crimping Tool (First Brand) is intended for crimping of Myval-Transcatheter Heart Valve for implantation; or CrocoDial - Transcatheter Heart Valve Crimping Tool (First Brand) intended for crimping of Transcatheter Heart Valve for implantation
Intracoronary Shunt
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
50ยตm Sirolimus Eluting Coronary Stent System
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Transcatheter Heart Valve System(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo ;)
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Transcatheter Heart Valve System
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Transcatheter Heart Valve(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo , Mavisโข, Eternisโข, Merineumโข, OCTACOR MyValโข OCTACOR )
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Biodegradable Polymer based Sirolimus Eluting Coronary Stent System(Biomime , Metafor , Biomime Aura , Biomime Morph , Proficient , Metaflex , Mabel , Biomime Lineage )
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Biodegradable Polymer based Sirolimus Eluting Coronary Stent System
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Vascular Closure Device
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
50ฮผm Everolimus Eluting Coronary Stent System(Peremo )
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Ventricular Septal Defect Occluder Delivery System(Lotus , Floret )
Brand: First Brand
Meril Life Sciences Pvt. Ltd.
Intracoronary Shunt
Brand: First Brand
50ยตm Sirolimus Eluting Coronary Stent System
Brand: First Brand
Balloon Expandable Peripheral Stent System(Myra BMS , Credence BMS )
Brand: PythonTM XL
Transcatheter Heart Valve System(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo ;)
Brand: First Brand
Transcatheter Heart Valve System
Brand: First Brand
Self-Expanding Nitinol Peripheral Stent System(Attune BMS, Promesa BMS )
Brand: PythonTM XL
Transcatheter Heart Valve(MyVal , MyVal Inception , MyVal Integra , MyVal Genesis , MyVal Eternis , MyVal Pulmo , MyVal Pro , MyVal Neo , Mavisโข, Eternisโข, Merineumโข, OCTACOR MyValโข OCTACOR )
Brand: First Brand
Balloon Expandable Renal & Biliary Stent System(Cogent BMS Melange BMS )
Brand: PythonTM XL
Biodegradable Polymer based Sirolimus Eluting Coronary Stent System(Biomime , Metafor , Biomime Aura , Biomime Morph , Proficient , Metaflex , Mabel , Biomime Lineage )
Brand: First Brand
Biodegradable Polymer based Sirolimus Eluting Coronary Stent System
Brand: First Brand