Sirolimus eluting coronary stent system - India CDSCO Medical Device Registration

Sirolimus eluting coronary stent system is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2022/000268_6c9c8e674ee317712f8dd72da8ce69bc_3619a002691c57cd541e568b59fd7cf7. This device is marketed under the brand name iVascular angiolite. The license holder is M/s. B.V Enterprise, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Sirolimus eluting coronary stent system

UID: IMP/MD/2022/000268_6c9c8e674ee317712f8dd72da8ce69bc_3619a002691c57cd541e568b59fd7cf7

Brand Name

iVascular angiolite

License Holder

M/s. B.V Enterprise

Device Class

Class D

Approving Authority

CDSCO

Product Information

The device is indicated for increasing the internal diameter of an artery with the aim of improving blood flow in the following cases: • Patients with symptomatic ischemic heart disease due to “de novo” stenotic and re-stenotic lesions located in arteries with diameters from 2mm to 4.5mm. • Patients with occlusive disease due to acute myocardial infarction located in arteries with diameters from 2mm to 4.5mm.