Sirolimus Eluting Coronary Stent System
- UID
- MFG/MD/2022/000680_dd9e936185c45bb38483da5470752fd4_fb59d52112c94a0308b43163629f8a09
- Device class
- Class D
- Brand name
- Eternia-AB
- License holder
- Innvolution Healthcare Pvt. Ltd.
- Approving authority
- CDSCO -North Zone, Ghaziabad
- Product information
- Sirolimus Eluting Coronary Stent system (Eternia-AB) is intended for use in the patient eligible for Percutaneous Transluminal Coronary Angioplasty (Eternia-AB). 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 ≤ 48 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/2022/000680_dd9e936185c45bb38483da5470752fd4_fb59d52112c94a0308b43163629f8a09. This device is marketed under the brand name Eternia-AB. The license holder is Innvolution Healthcare Pvt. Ltd., and it is classified as Device Class Class D. The approving authority is CDSCO -North Zone, Ghaziabad.
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