Biodegradable Polymer based Sirolimus Eluting Coronary Stent System(Biomime , Metafor , Biomime Aura , Biomime Morph , Proficient , Metaflex , Mabel , Biomime Lineage ) - India CDSCO Medical Device Registration

Biodegradable Polymer based Sirolimus Eluting Coronary Stent System(Biomime , Metafor , Biomime Aura , Biomime Morph , Proficient , Metaflex , Mabel , Biomime Lineage ) is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2018/000028_db26b06d72284d7836c44763adeed2e9_65f841e68d8e9b7e21fe9bf50e01e372. 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

Biodegradable Polymer based Sirolimus Eluting Coronary Stent System(Biomime , Metafor , Biomime Aura , Biomime Morph , Proficient , Metaflex , Mabel , Biomime Lineage )

UID: MFG/MD/2018/000028_db26b06d72284d7836c44763adeed2e9_65f841e68d8e9b7e21fe9bf50e01e372

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

It is indicated for improving coronary luminal diameter in the following:Patients with symptomatic ischemic heart disease due to discretede novo native coronary artery lesions.For restoring coronary flow in patients experiencing acute myocardial infarction whopresent within 12 hours of symptom onset.For the treatment of patients with concomitant diabetes, acute coronary syndrome, dual vessel lesions (First Brand), lesions residing within small coronary vessels; lesions where treatment results in the jailing of side branches (First Brand); for the treatment of elderly patients (First Brand), and for treatment of both men and women.For the treatment of patients presenting with in-stentrestenosis in coronary artery lesions; chronic total occluded coronary artery lesions (First Brand); and coronary artery bifurcation lesions.In all cases ;For Linear models the treated lesion length should be ≤ 44mm with reference vessel diameter of 2.00 mm to 4.50 mm.For Tapered models the treated lesion length should be ≤ 56mm with reference vessel diameter of 2.25 mm to 3.50 mm for global market/export purpose only

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Intracoronary Shunt

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 ) - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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