Coronary Stent Graft System - India CDSCO Medical Device Registration

Coronary Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000511_8d23489fd3c4737d3e2cc30e56c19905_9de5c0f41866b124f4d40c700823b9eb. 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 Graft System

UID: IMP/MD/2019/000511_8d23489fd3c4737d3e2cc30e56c19905_9de5c0f41866b124f4d40c700823b9eb

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

The 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: • 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.