Coronary Stent System
- UID
- IMP/MD/2019/000511_0f0e5f038f5f9be051a98a006bceff3e_e794312a27a0bff7ee0ffb9e0369e843
- Device class
- Class D
- Brand name
- Xience Prime , Xience Prime SV and Xience Prime LL Everolimus Eluting Coronary Stent System
- License holder
- Abbott Healthcare Private Limited
- 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
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.
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