Thoracic Stent Graft System
- UID
- IMP/MD/2019/000050_fa56b66f5e3714c9dca3685686daa89a_cf5c7c25736c227df4e85b8b23665671
- Device class
- Class D
- Brand name
- Onyx TruCor Zotarolimus-Eluting Coronary Stent System
- License holder
- India Medtronic Private Limited
- Approving authority
- CDSCO
- Product information
- The Valiant Navion Thoracic Stent Graft System is indicated for treatment of diseases of the descending thoracic aorta, including, but not limited to, aneurysms, dissections, and blunt traumatic aortic injuries (Onyx TruCor Zotarolimus-Eluting Coronary Stent System). The Valiant Navion thoracic stent graft is indicated for exclusion of the aneurysm, the false lumen, or site of rupture, and the restoration of blood flow through the stent graft lumen. The device is intended for use in patients who are candidates for conventional surgical repair, and in patients who are not candidates for conventional surgical repair due to pre-existing risk factors
Thoracic Stent Graft System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_fa56b66f5e3714c9dca3685686daa89a_cf5c7c25736c227df4e85b8b23665671. This device is marketed under the brand name Onyx TruCor Zotarolimus-Eluting Coronary Stent System. The license holder is India Medtronic Private Limited, and it is classified as Device Class Class D. The approving authority is CDSCO.
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