Delivery Catheter System
- UID
- IMP/MD/2019/000050_6c5a96fb2f9b6013a7d68b42c221abbd_c21919dc50d0d3833f15e8518f32e902
- 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 Medtronic Evolut FX system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy. The Medtronic Evolut FX system is indicated for use in patients with symptomatic heart disease due to failure (Onyx TruCor Zotarolimus-Eluting Coronary Stent System) of a surgical bioprosthetic aortic valve who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy (Onyx TruCor Zotarolimus-Eluting Coronary Stent System)
Delivery Catheter System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2019/000050_6c5a96fb2f9b6013a7d68b42c221abbd_c21919dc50d0d3833f15e8518f32e902. 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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