CDSCO UID IMP/MD/2020/000227_e045c4a4e62fda8d6f58b178c98afb3c_aceedac64215f189fcd19c71a3d641da

Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer.

M/s Saihealth Innovation·Device Class Class D·India CDSCO·Brand: iVascular angiolite
Registration details
UID
IMP/MD/2020/000227_e045c4a4e62fda8d6f58b178c98afb3c_aceedac64215f189fcd19c71a3d641da
Device class
Class D
Brand name
iVascular angiolite
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..
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About this record

Sirolimus eluting coronary stent system, with CoCr Stent and permanent polymer. is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000227_e045c4a4e62fda8d6f58b178c98afb3c_aceedac64215f189fcd19c71a3d641da. This device is marketed under the brand name iVascular angiolite. The license holder is M/s Saihealth Innovation, and it is classified as Device Class Class D. The approving authority is CDSCO.

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