Sirolimus Eluting Coronary Stent System
- UID
- MFG/MD/2019/000057_dd9e936185c45bb38483da5470752fd4_a1e1c344717bf41cc7c064d046fa792d
- Device class
- Class D
- Brand name
- TM under process
- License holder
- KAMAL ENCON INDUSTRIES LIMITED
- Approving authority
- Sub Zonal Baddi
- Product information
- Sirolimus Eluting Coronary Stent System is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (TM under process). Sirolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length 40 mm in native coronary arteries with a reference vessel diameter of 2.00 to 4.50 mm
Sirolimus Eluting Coronary Stent System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2019/000057_dd9e936185c45bb38483da5470752fd4_a1e1c344717bf41cc7c064d046fa792d. This device is marketed under the brand name TM under process. The license holder is KAMAL ENCON INDUSTRIES LIMITED, and it is classified as Device Class Class D. The approving authority is Sub Zonal Baddi.
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