Sirolimus Eluting Stent System - Cobalt Chromium
- UID
- MFG/MD/2021/000107_366c48032ec678b24bc64dbb1280ea85_a3f74ce8c3d87a5279b9720c55e093ce
- Device class
- Class D
- Brand name
- Speed - PTCA Catheters
- License holder
- M/s Microtrol Sterilisation Services Private Limited
- Approving authority
- Sub Zonal Bangalore
- Product information
- The ProNOVA Coronary Stent System is indicated for use in patients with symptomatic ischemic heart disease due to discrete de novo artery lesions (Speed - PTCA Catheters) with a reference vessel diameter ranging from 2.0mm to 4.0mm (Speed - PTCA Catheters) and is intended to improve coronary luminal diameter. Long term outcome for this permanent implant is unknown at present.
Sirolimus Eluting Stent System - Cobalt Chromium is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2021/000107_366c48032ec678b24bc64dbb1280ea85_a3f74ce8c3d87a5279b9720c55e093ce. This device is marketed under the brand name Speed - PTCA Catheters. The license holder is M/s Microtrol Sterilisation Services Private Limited, and it is classified as Device Class Class D. The approving authority is Sub Zonal Bangalore.
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