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_e794312a27a0bff7ee0ffb9e0369e843. 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.

This page provides comprehensive regulatory information including complete registration details, license holder information, device classification, and related products. Pure Global AI offers free access to 71,807+ India medical device registrations, helping global MedTech companies identify partners, analyze markets, and discover business opportunities efficiently.

Free Database

CDSCO Registered

Class Class D

Coronary Stent System

UID: IMP/MD/2019/000511_0f0e5f038f5f9be051a98a006bceff3e_e794312a27a0bff7ee0ffb9e0369e843

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

GraftMaster RX is a balloon-expandable pre-mounted coronary stent graft for intraluminal chronic placement in coronary arteries or aorto-coronary bypass grafts for the treatment of: •Coronary artery aneurysm •Coronary bypass-vein graft aneurysm •Acute coronary artery perforation •Acute coronary artery rupture Patients being considered for stent graft implantation should be acceptable for coronary artery bypass graft surgery, and / or for coronary balloon angioplasty with ischemic heart disease due to discrete de novo or restenotic native coronary lesions