Coronary Stent System - India CDSCO Medical Device Registration

Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000511_0f0e5f038f5f9be051a98a006bceff3e_28fa7791177f692a0aeb9bd55275ec17. This device is marketed under the brand name Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System. The license holder is Abbott Healthcare Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.

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CDSCO Registered

Class Class D

Coronary Stent System

UID: IMP/MD/2019/000511_0f0e5f038f5f9be051a98a006bceff3e_28fa7791177f692a0aeb9bd55275ec17

Brand Name

Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System

License Holder

Abbott Healthcare Private Limited

Device Class

Class D

Approving Authority

CDSCO

Product Information

Multi-Link 8, Multi-Link 8 SV, and Multi-Link 8 LL Coronary Stent Systems are indicated for improving coronary luminal diameter in the following: Multi-Link 8: Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 3.0 mm to 4.0 mm. Multi-Link 8 SV: Patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.0 mm to 2.5 mm. Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.25 mm to 2.5 mm. Multi-Link 8 LL: Patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Restoring coronary flow in patients experiencing acute myocardial infarction, who within 12 hours of symptom onset present with native coronary artery lesions (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 2.5 mm to 4.0 mm. Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System) with reference vessel diameters from 3.0 mm to 4.0 mm

Class D

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Brand: Xience Alpine™ Everolimus Eluting Coronary Stent System

Class D