50µm Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

50µm Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_fd32fb2cb02183bc1e2ff9109a95975c_59a3dda65c59e582d937e060a9ab2266. 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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CDSCO Registered

Class Class D

50µm Sirolimus Eluting Coronary Stent System

UID: MFG/MD/2018/000028_fd32fb2cb02183bc1e2ff9109a95975c_59a3dda65c59e582d937e060a9ab2266

Brand Name

First Brand

License Holder

Meril Life Sciences Pvt. Ltd.

Device Class

Class D

Approving Authority

Central Drug Standards Control Organization, Ahmedabad

Product Information

Cylindrical Model: It is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo & in-stent restenotic lesions (First Brand) in native coronary arteries with a reference vessel diameter of 2.00 mm to 4.50 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (First Brand) and Stenting procedures.; Taper Model: It is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to de novo & in-stent restenotic lesions (First Brand) in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.50 mm in patients eligible for Percutaneous Transluminal Coronary Angioplasty (First Brand) and Stenting procedures

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Intracoronary Shunt

Brand: First Brand

Meril Life Sciences Pvt. Ltd.

50µm Sirolimus Eluting Coronary Stent System - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

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Intracoronary Shunt

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